Filter Results
Conditions
Locations
Treatment Type
Trial Phase
Trial Status
Paid Participation
Clear All
69 Cognitive Impairment Trials near San Francisco, CA
Power is an online platform that helps thousands of Cognitive Impairment patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerBIIB080 for Alzheimer's Disease
San Francisco, CaliforniaIn this study, researchers will learn more about a study drug called BIIB080. The study will focus on participants with mild cognitive impairment or mild dementia due to AD.
The main question researchers are trying to answer is if BIIB080 can slow the worsening of AD more than placebo. It will focus on what dose of BIIB080 slows worsening of AD the most.
To help answer this question, researchers will use the Clinical Dementia Rating-Sum of Boxes, also known as the CDR-SB.
* Clinicians use the CDR-SB to measure several categories of dementia symptoms.
* The results for each category are added together for a total score. Lower scores are better.
Researchers will also learn more about the safety of BIIB080.
The study will be split into 2 parts. The 1st part is the Placebo-Controlled Period. The 2nd part is the Long-Term Extension (LTE) Period. The 2nd part of the study will help researchers learn about the long-term safety of BIIB080, and how it affects the participant's daily life, thinking, and memory abilities in the longer term.
A description of how the study will be done is given below.
* After screening, participants will first receive either a low dose or high dose of BIIB080, or a placebo, as an injection into the fluid around the spinal cord (cerebrospinal fluid). A placebo looks like the study drug but contains no real medicine.
* Participants will receive BIIB080 or placebo once every 12 weeks or 24 weeks.
* After 76 weeks of treatment in the Placebo-Controlled Period, eligible participants will move onto the Extension Treatment period, which will last 96 weeks.
* In the extension period, participants who received placebo will be switched to high dose BIIB080 every 12 or 24 weeks.
* Participants may be in the study for up to 201 weeks, or about 4 years. This includes the screening and follow-up periods.
* Participants can continue to take certain medications for AD. Participants must be on the same dose of medication for at least 8 weeks before the screening period.
* After the screening period, most participants will visit the clinic every 6 weeks.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:50 - 80
Sex:All
416 Participants Needed
Tau Tracer Comparison for Alzheimer's Disease
San Francisco, CaliforniaThis trial uses special imaging agents to help visualize harmful brain proteins in people at risk of Alzheimer's disease. The agents make these proteins glow during scans, allowing doctors to see them clearly and monitor the disease.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:50 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnant, Breastfeeding, Cognitive Impairment, Others
620 Participants Needed
Digital Interventions for Mild Cognitive Impairment
San Francisco, CaliforniaThe goal of this proposed research is to collect pilot data to test the hypothesis that treatment with a novel form of closed-loop digital meditation (MediTrain) will lead to a greater magnitude of gains in cognitive abilities in patients with mild cognitive impairment (MCI), compared to OA without cognitive impairment, and will lead to improvements in quantitative measures of sleep.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60 - 85
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological, Psychiatric, Seizures, Glaucoma, Others
Must Not Be Taking:Antidepressants, Antianxiety
90 Participants Needed
Noninvasive Brain Stimulation for Mild Cognitive Impairment
San Francisco, CaliforniaThe overall goal of this project is to collect pilot feasibility and early efficacy data showing improvements in cognition and wellbeing in adults with mild cognitive impairment (MCI) through a combination treatment of non-invasive brain stimulation (transcranial alternating current stimulation (tACS)) and a one of two digital cognitive interventions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60 - 85
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological, Psychiatric, Seizures, Others
Must Not Be Taking:Antidepressants, Antianxiety
90 Participants Needed
Digital Therapeutics for Cognitive Decline
San Francisco, CaliforniaThe goals of the proposed research are to first determine the minimal and/or optimal dose of a digital intervention required for cognitive enhancement, and then to examine the impact of several potential moderators of treatment effects (i.e., cognitive decline, AD polygenic hazard score, cardiovascular risk, and race/ethnicity). This knowledge gained from his high-impact study with transform the field of cognitive interventions, paving the way for a precision medicine model for cognitive enhancing interventions that improve quality of life for older adults and individuals with cognitive deficits at risk of developing dementia.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60 - 99
Sex:All
Key Eligibility Criteria
Disqualifiers:Under 60 Years Old
4000 Participants Needed
Cognitive Training for Breast Cancer Survivors
San Francisco, CaliforniaThis Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 100
Sex:All
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Other Cancer, CNS Radiation, Stroke, Substance Abuse, Others
386 Participants Needed
Cognitive Training for Mild Cognitive Impairment
San Francisco, CaliforniaOlder adults at risk for dementia show a variety of cognitive deficits, which can be ameliorated by different cognitive training (CT) exercises. The best combination of CT exercises is unknown. The aim is to discover the most efficacious combination of CT exercises as compared to cognitive stimulation (which will serve as a stringent, active control) to modify the functional trajectories of older adults' with MCI, who are at high risk for dementia. The primary objective of the U01 phase was to design and pilot-test an adaptive, randomized clinical trial (RCT) of cognitive training (CT) combinations aimed to enhance performance of instrumental activities of daily living (IADL) among persons with mild cognitive impairment (MCI). In the R01 phase, the objective is to identify the best combination of CT exercises to delay dementia onset among persons with MCI. The longitudinal endpoint goal is reducing incident dementia. The primary aim of the study is to determine which CT combination has the best probability to delay dementia by producing the largest IADL improvements. The study further aims to explore neuroimaging and novel blood-based biomarkers.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:55 - 89
Sex:All
Key Eligibility Criteria
Disqualifiers:Dementia, Stroke, Parkinson's, Others
1305 Participants Needed
BMS-986446 for Early Alzheimer's Disease
San Francisco, CaliforniaThis trial is testing a new medication called BMS-986446 in people with early Alzheimer's disease. The medication is designed to target harmful proteins in the brain to slow down the disease. Researchers are checking if it works well and is safe for patients.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Other Cognitive Conditions, MRI Contraindications, Others
475 Participants Needed
Music Improvisation for Cognitive Aging
San Francisco, CaliforniaThis project will study the effects and mechanisms of a music improvisation training intervention on self-regulation of older adults with and without MCI. The investigator's overall hypothesis is that improvisation training will lead to improvements in self-regulation, compared to controls, and that improvisation training will be associated with specific changes in prefrontal brain networks and ultimately cognitive engagement.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60+
Sex:All
Key Eligibility Criteria
Disqualifiers:Dementia, Severe Psychiatric Disorder, Others
Must Not Be Taking:Psychoactive, Antidepressants, Sleep Medications
238 Participants Needed
Online Wellness Interventions for Cognitive Impairment
San Francisco, CaliforniaThe purpose of this study is to compare the effects of three on-line wellness interventions for improving physical and cognitive function and brain connectivity in adults who are at least 55 years old and are experiencing symptoms of memory and/or cognitive difficulties.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:55+
Sex:All
80 Participants Needed
Immersive Video Games for Cognitive Impairment
San Francisco, CaliforniaTherapeutic treatment is yet available for declining memory, which is an impairment affecting the quality of life for many older adults and patients with cognitive impairment. Cognitive training with an immersive video game promises to drive hippocampal-cortical plasticity and associated gains that can restore memory capability or provide therapeutic treatment for memory deficits.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60 - 85
Sex:All
Key Eligibility Criteria
Disqualifiers:Concussions, Dizziness, Balance Problems, Others
Must Not Be Taking:Psychotropic Medications
200 Participants Needed
Reduced-THC Cannabis for Cognitive Impairment from Cannabis Use
San Francisco, CaliforniaThe goal of this interventional study is to determine the impact of high potency THC product use on cognitive function of young adults aged 21-25.
The main question it aims to answer is: will cannabis users who switch to less potent THC products demonstrate improved cognitive function compared to baseline?
Other questions this study aims to answer include:
* Can researchers accurately assess THC consumption among frequent cannabis users?
* Can researchers effectively incentivize cannabis users to use less potent THC products?
* Do genetic variations in THC metabolism impact urinary THC excretion?
* Do genetic variations in THC metabolism impact cognitive performance in cannabis users?
* Are quantitative urinary THC values predictive of cognitive impairment?
* How can researchers use research findings to inform harm reduction practices for people who use cannabis?
Participants will submit blood and urine samples and be incentivized to use less potent THC products.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 25
Sex:All
110 Participants Needed
Pramipexole vs Escitalopram for Depression in HIV
San Francisco, CaliforniaA phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes.
An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 70
Sex:All
186 Participants Needed
Donanemab for Early Alzheimer's Disease
San Francisco, CaliforniaThis trial is testing donanemab, a drug for early Alzheimer's disease. It targets people with early symptoms and specific brain changes. The drug helps remove harmful proteins from the brain, potentially slowing down or improving symptoms.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60 - 85
Sex:All
1736 Participants Needed
Cognitive Rehabilitation for Brain Tumor
San Francisco, CaliforniaPatients with glial brain tumors have increasingly improved outcomes, with median survival of 5-15 years. However, the treatments, including surgery, radiation, and chemotherapy, often lead to impaired attention, working memory, and other cognitive functions. These cognitive deficits frequently have significant impact on patient quality of life. Although currently, there is no established standard of care to treat cognitive deficits in brain tumor patients, standard cognitive rehabilitative treatments have been developed for those with traumatic brain injury and stroke. However, the feasibility and efficacy of these cognitive treatments in individuals with brain tumors remains unclear.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
97 Participants Needed
TranS-C for Mild Cognitive Impairment
Berkeley, CaliforniaThe main empirical question to be addressed is: What types of memory support are most potent for patients who are experiencing a mild cognitive impairment (MCI) relative to non-MCI patients?
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60+
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Illness, Degenerative Disease, Night Shift, Others
80 Participants Needed
Precision Medicine for Dementia
San Rafael, CaliforniaThe goal of this clinical trial is to compare a precision medicine approach to the standard-of-care for people with mild cognitive impairment or early-stage dementia. Precision medicine approach starts with the completion of many tests and then the study doctor uses the test results to carefully prepare a treatment plan that is best for the individual person to help treat many of the underlying causes of mild cognitive impairment or early-stage dementia.
The main question the study aims to answer is:
• Does the precision medicine approach improve memory (cognitive function) better than the current standard-of-care treatment in people with mild cognitive impairment or early-stage dementia during a 9-month treatment period? This is a randomized clinical trial which means that a group of people that meet the study requirements will be assigned at random or by chance (like toss of a coin) to receive either the precision medicine treatment or the current gold standard (standard-of-care). People assigned to the precision medicine group will receive precision medicine for 9-months while those assigned to the standard-of-care group will follow that approach for 9-months, followed by an opportunity to receive up to six months of precision medicine, if desired.
Participants will be asked to:
* Have their blood drawn for extensive lab testing and collect urine and stool samples as well
* Carefully follow instructions received from their study doctor and study team
* Make lifestyle changes as prescribed by the study doctor and study team based on your precision medicine program
* Take supplements and medications prescribed by the study doctor.
* Once officially in the study (after meeting study entry or screening requirements), participate in ten (10) monthly visits with the study doctor, and other members of the study team as scheduled.
* Complete cognitive tests at scheduled visits during the study
* Have a study partner with you during visits and to help support you on the program Researchers will compare test results between the two study groups to see if the precision medicine approach improves those tests results over the time of the study, resulting in the improvement of cognition over a 9-month treatment period.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:45 - 76
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Illness, Type 1 Diabetes, Cancer, Others
Must Be Taking:Aricept
72 Participants Needed
Light Therapy for Sleep Disorders and Cognitive Impairment
Redwood City, CaliforniaThis trial will examine scheduled exposure to bright light in the morning and afternoon as a countermeasure to sleep fragmentation in older individuals with mild cognitive impairment.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:65 - 99
Sex:All
120 Participants Needed
Senicapoc for Alzheimer's Disease
Walnut Creek, CaliforniaThis trial tests Senicapoc, a drug that may reduce brain inflammation, in patients with early-stage Alzheimer's disease. The goal is to see if it can slow down memory loss and other symptoms by protecting brain cells.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:55 - 85
Sex:All
Key Eligibility Criteria
Disqualifiers:Unstable Illnesses, Psychiatric Illness, Drug Abuse, Others
Must Be Taking:Cholinesterase Inhibitors, Memantine
55 Participants Needed
Financial Incentives for Alzheimer's Prevention
Martinez, CaliforniaThis single-blind, three-arm, randomized, controlled trial will assess the impact of messages and financial incentives on the enrollment of demographically diverse individuals to the Alzheimer Prevention Trials (APT) Webstudy. The APT Webstudy is a novel, online registry that employs quarterly cognitive testing using validated platforms. The APT Webstudy implements fully remote assessments, coordinated by the Alzheimer's Therapeutic Research Institute (ATRI) under USC IRB #HS-17-00746. The purpose of the current study is to test whether we can increase enrollment of diverse individuals into the registry. To do this, we will work with Contra Costa Regional Medical Center (CCRMC), the county public hospital and its affiliated health centers in Contra Costa County, California, to test whether sending messages with and without financial incentives to patients who receive primary care with the health system can increase enrollment to the APT Webstudy. The investigators hypothesize that 1) a certain small financial incentive and an award opportunity based incentive (or a drawing with a prize) will increase enrollment rates of CCHS members into the APT Webstudy relative to the control group. The investigators further hypothesize that the award opportunity incentive will increase the enrollment rate of CCRMC patients into the APT Webstudy more than a certain financial incentive with the same expected value.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Sex:All
Key Eligibility Criteria
Disqualifiers:Below Age 50, Dementia Diagnosis
48000 Participants Needed
Darbepoetin for Preterm Infants
Palo Alto, CaliforniaStudy Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:1 - 24
Sex:All
650 Participants Needed
Metformin for Alzheimer's Disease
Palo Alto, CaliforniaMAP will be a multisite phase II/III 1:1 randomized controlled trial (RCT) of long acting metformin (reduced mass Glucophage XR) vs. matching placebo in 326 men and women with early and late aMCI, without diabetes, not treated with metformin, overweight or obese, aged 55 years to 90 years. The RCT will last 18 months and have 4 visits: baseline, 6-months, 12-months, and 18-months. The RCT will be preceded by a screening phase followed by randomization and a titration period in which drug/placebo will be titrated from 500 mg a day (one tablet) to 2,000 mg a day (4 tablets), in increments of 500 mg (one tablet) every 10 days. Participants will remain in the RCT on the tolerated dose, and included in analyses on an intent to treat basis. We expect the attrition rate to be 10%/year. Neuropsychological battery, clinical interviews, physical exam, and phlebotomy will be conducted at baseline and every 6 months. Brain MRI will be conducted in approximately half of the participants (186) twice, at baseline, and after the last study visit at month 18. We will also conduct brain amyloid Positron Emission Tomography (PET) using 18F-Florbetaben, and tau PET using 18F-MK6240 in half of the participants at baseline and end of the RCT.
The primary clinical outcome of the study will be changes in the Free and Cued Selective Reminding Test. The secondary endpoints are 1) changes in global cognitive performance, measured with the Alzheimer's Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC); 2) changes in neurodegeneration, ascertained as cortical thickness in areas affected by AD on brain MRI; 3) changes in cerebrovascular disease, ascertained as white matter hyperintensities (WMH) volume on brain MRI; 4) Changes in whole brain amyloid ß (Aß) SUVR and in incident amyloid positivity; 5) Changes in tau SUVR in a composite brain region comprising medial and inferolateral temporal cortex; 6) Changes in plasma AD biomarkers.
The data coordinating center and Imaging Core is located at John Hopkins University. The PET coordinating center is located at UC-Berkeley. The Clinical Coordinating and Monitoring Center and the central laboratory will be located at Columbia. The Research pharmacy function will be shared by the University of Rochester, which will dispense randomization kits, and the University of Iowa, which will receive bulk metformin and identical matching placebo from EMD Serono.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:55 - 90
Sex:All
326 Participants Needed
Water-Based Exercise + Cognitive Training for Mild Cognitive Impairment
Palo Alto, CaliforniaThis four-year study will evaluate the efficacy of an exercise training augmentation for cognitive training intervention to improve memory performance in Veterans with a diagnosis of amnestic Mild Cognitive Impairment (aMCI). This is a two-phased trial: 1) an exercise phase and 2) a cognitive training program. The exercise phase will be an aquatic based exercise program. A combination of exercise and cognitive training programs designed for persons without cognitive impairment have significantly improved memory more than other single intervention groups (exercise only, cognitive training only) and given the success of combination training programs with healthy older adults, it is important to adapt these programs for persons beginning to exhibit clinically significant memory problems, such as those with aMCI.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:50 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Dementia, Stroke, Others
130 Participants Needed
JNJ-63733657 for Alzheimer's Disease
Palo Alto, CaliforniaThis trial is testing a new drug called JNJ-63733657 to see if it can help slow down the worsening of symptoms in patients with Alzheimer's disease. The goal is to see if the drug can help maintain brain function and daily living skills better.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:55 - 80
Sex:All
523 Participants Needed
Cognitive Training for Cognitive Impairment
Palo Alto, California(JUSTIFICATION: This is the R33 stage of an NIH funded R21/R33 study. R21 stage (IRB-61727) was focused on intervention development; R33 stage will focus on pilot testing the effect of the intervention. The R21 phase was not considered a NIH defined clinical trial; R33 will be considered a NIH defined clinical trial)
The purpose is to develop and test the effect of a "personalized" computer-based cognitive training program. The personalized program tailors the difficulty of the training tasks using a participant's biofeedback (i.e., heart rate) and cognitive performance. Such a personalization will ensure that the participant can perform at his/her ideal training capacity. Participants will be randomized into one of 2 groups and each group will play a different version of computerized training game and have ECG collected to allow subject blinding.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:60+
Sex:All
Key Eligibility Criteria
Disqualifiers:Major Depression, Cardiovascular Diseases, Neurological Conditions, Others
50 Participants Needed
Supportive Care for Dementia
Palo Alto, CaliforniaCurrently almost 5 million Americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. The overall goals of the proposed project are to evaluate, in community dwelling Alzheimer's Disease Research Center participants the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, health care resource use. The relevance of this research to public health is that there is an urgent need to improve the palliative care of persons with dementia living in the community. This study will contribute substantially to that effort.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:65+
Sex:All
200 Participants Needed
RTMS for Dementia
Palo Alto, CaliforniaThe purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS) improves cognitive function in patients with neurodegenerative conditions which may manifest as mild to moderate cognitive impairment and, in late phase, dementia. This study also intends to investigate if the responses to rTMS intervention are either positively or negatively correlated with the initial severity of cognitive impairment.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:55 - 99
Sex:All
32 Participants Needed
STN+NBM DBS for Mild Cognitive Impairment in Parkinson's Disease
Stanford, CaliforniaThe goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is:
Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled.
Participants will undergo a modification of the traditional STN DBS approach for motor symptoms of PD. In addition to the two leads placed within the STN, two additional leads will be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel stimulation patterns will be used within the NBM to target cognitive and cognitive-motor symptoms using an investigational software. Participants will be followed over two years while receiving this therapy with assessments at baseline and every six months. Assessments will include a combination of neuropsychological evaluations, cognitive assessments, motor tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different surgical trajectories will be used, with half the cohort randomized to each group. This will allow comparison of the impact of surgical trajectory on the intervention.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Dementia, Seizures, Untreated Depression, Others
10 Participants Needed
Math & Cognitive Skill Interventions for Dyscalculia
Palo Alto, CaliforniaThe purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6 - 12
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological, Psychiatric, Head Injury, Others
Must Not Be Taking:Psychiatric Medications
180 Participants Needed
Sleep Therapies for Alzheimer's Disease
Palo Alto, CaliforniaRecent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treating sleep disruption reduces these symptoms. Impairments in the neural systems that support emotion regulation may represent one causal mechanism mediating the relationship between sleep and emotional distress. However, this model has not yet been formally tested within a sample of individuals with or at risk for developing Alzheimer's Disease (AD)
This proposal aims to test a mechanistic model in which sleep disturbance contributes to neuropsychiatric symptoms through impairments in fronto-limbic emotion regulation function in a sample of individuals at risk for developing, or at an early stage of AD.
This study seeks to delineate the causal association between sleep disruption, fronto-limbic emotion regulation brain function, and neuropsychiatric symptoms. These aims will be achieved through a mechanistic, randomized 2-arm controlled trial design. 150 adults experiencing sleep disturbances and who also have cognitive impairment with the presence of at least mild neuropsychiatric symptoms will be randomized to receive either a sleep manipulation (Cognitive Behavioral Therapy for Insomnia CBT-I; n=75) or an active control (n=75). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, fronto-limbic functioning, and sleep disruption will be assessed at baseline and at the end of the sleep manipulation through functional Magnetic Resonance Imaging (fMRI), clinical interviews, PSG recordings, and self-report questionnaires. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (actigraphy, Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout the sleep manipulation to assess week-to-week changes following an increasing number of CBT-I sessions. Wristwatch actigraphy will be acquired from baseline to the end of the sleep manipulation at week 11. Neuropsychiatric symptoms and sleep will be assessed again at six months post-manipulation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Bipolar, Psychosis, Substance Abuse, Others
Must Not Be Taking:Sleep Medications, Antidepressants
150 Participants Needed
Page 1 of 3+
Learn More About Power
My name is Bask, and I helped to start the company here. We started Power when my Dad was diagnosed with multiple myeloma, and I needed a better way to understand how he could access the most promising immunotherapy for his illness.
Bask GillCEO at Power
Frequently Asked Questions
How much do Cognitive Impairment clinical trials in San Francisco, CA pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Cognitive Impairment clinical trials in San Francisco, CA work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Cognitive Impairment trials in San Francisco, CA 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in San Francisco, CA for Cognitive Impairment is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in San Francisco, CA several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Cognitive Impairment medical study in San Francisco, CA ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Cognitive Impairment clinical trials in San Francisco, CA ?
Most recently, we added Light Therapy for Sleep Disorders and Cognitive Impairment, Photobiomodulation for Cancer-Related Cognitive Impairment and Pramipexole vs Escitalopram for Depression in HIV to the Power online platform.