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57 Cognitive Impairment Trials
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.
Minocycline for Cognitive Decline in Sickle Cell Disease
Cincinnati, OhioSickle cell disease (SCD) is a common, inherited blood disorder that primarily affects people of African Ancestry. It has a lot of complications including neurological complications. The neurological complications of SCD are particularly devastating and lead to cognitive decline even in the absence of overt brain injury. In such cases, it is thought that inflammation in the brain maybe partly responsible for the cognitive decline.
The main reasons for this research study are to see 1) how safe and 2) how well minocycline works to try to stop/reverse cognitive decline in people with SCD. People with SCD are at risk for changes in their brain over time that can cause problems with learning, memory, and attention. Part of the reason for this is inflammation within the brain. Minocycline may be able to stop these brain changes by stopping this brain inflammation.
Minocycline is a second-generation tetracycline antibiotic that has been shown to both inhibit neuroinflammation and improve cognitive function in a variety of neurodegenerative and psychiatric disorders but has not yet been studied in SCD. We are proposing here, a pilot double-blinded, randomized controlled trial to examine the tolerability and early efficacy of minocycline in adults with SCD at two dosing regimens (200 mg and 300 mg daily) versus placebo over one year. Participants will undergo a neuropsychological exam using the NIH Toolbox Cognition Battery at both study enrollment and exit (after one year) to assess for changes/stability of cognition. Participants will receive monthly phone calls/text messages to assess for adverse events and will be seen every three months for pill counts and routine laboratory monitoring. The primary outcome will be a comparison of adverse events across the two dosing strategies versus placebo. Early evidence for cognitive benefit will also be assessed from the results of the NIH Toolbox.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
30 Participants Needed
Pramipexole vs Escitalopram for Depression in HIV
Columbus, OhioA 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
Varenicline for Parkinson's Disease
Ann Arbor, MichiganThis trial aims to test whether one year of Varenicline, when compared to placebo, can reduce fall risk and show improvement in the ability to multitask while walking.
Participants that are eligible after screening for the study will be randomized to receive Varenicline or placebo. Along with the study medication participants will have visits (over the phone and in person), various tests and imaging, questionnaires, and laboratory collections.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:45+
Sex:All
102 Participants Needed
Tai Chi for Mild Cognitive Impairment
Athens, OhioMild Cognitive Impairment (MCI) in older adults is linked to muscle loss (sarcopenia) and can lead to dementia, with pain further impacting cognitive and physical performance. Tai Chi, a mind-body exercise, is recommended for managing MCI as it supports cognitive function, mood, and physical health.
The investigators' first goal is to characterize the correlation of heart rate variability and cortical activity on cognitive function and the psychosocial correlates of pain interference and social isolation on cognitive function at baseline and post-intervention (8 weeks of Tai Chi). The second goal is to explain the role of sarcopenia and obesity in the relationship between pain interference and cognitive function. The investigators also want to examine the index of the predictive capacity regarding sarcopenia and obesity on cognitive function outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60+
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Cardiovascular, Respiratory, Metabolic, Others
50 Participants Needed
tDCS for Cognitive Impairment
Pittsburgh, PennsylvaniaThe objective is to evaluate if neuromodulation of the PFC can acutely improve sensory integration for balance performance in OTTBCS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60 - 85
Sex:Female
Key Eligibility Criteria
Disqualifiers:Gait Disorder, Parkinson's, Alzheimer's, Others
Must Not Be Taking:Anti-epileptic, Neuro-active Drugs
20 Participants Needed
LY3954068 for Alzheimer's Disease
Indianapolis, IndianaThe main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.
The study will be comprised of two parts, A and B. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid.
The study will last up to approximately 45 weeks for Part A, and, if conducted, 73 weeks for Part B, including the screening period.
If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 96 weeks, including the screening period.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:50 - 85
Sex:All
Key Eligibility Criteria
Disqualifiers:Serious Illnesses, MRI Contraindications, Others
Must Not Be Taking:Amyloid Therapies, Anti-tau Therapies
32 Participants Needed
Self-Management Program for Chronic Pain and Cognitive Impairment
Ann Arbor, MichiganThe goal of this randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic pain and cognitive impairment. The main questions it aims to answer are whether this program is feasible and acceptable, and whether it shows potential for improving pain-related outcomes. Intervention group participants will receive education and support from a community health worker in 7 weekly telephone sessions, and will watch a series of educational videos discussing a variety of chronic pain self-management skills. A control group will not receive the program, but after the final data collection point will be invited to attend a one-time remote session that summarizes intervention content, and will receive all program materials. Researchers will compare intervention and control groups after the program ends to see if the intervention group has less pain interference with daily activities.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50+
Sex:All
Key Eligibility Criteria
Disqualifiers:Serious Acute Illness, Major Surgery, Others
57 Participants Needed
Brain Stimulation for Mild Cognitive Impairment
Ann Arbor, MichiganThis study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in cognitively intact older adults (healthy controls, HC) and in those with mild cognitive impairment (MCI).
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60+
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Conditions, Mental Illness, Sensory Impairments, Alcohol Or Drug Abuse, Others
80 Participants Needed
Cognitive Training for Breast Cancer Survivors
Columbus, OhioThis 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
Xanamem for Alzheimer's Disease
Dayton, OhioXanamem® is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD).
This XanaMIA Phase 2b/3 study is to investigate the safety, tolerability, and efficacy of Xanamem in in mild or moderate dementia due to AD. Trial participants will be randomized to either receive 10mg of Xanamem once daily or a placebo for 36 weeks at a 1:1 ratio in a double-blinded fashion.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50+
Sex:All
Key Eligibility Criteria
Disqualifiers:Non-AD Dementia, Major Mental Illness, Diabetes, Others
Must Be Taking:Symptomatic AD Medications
220 Participants Needed
Time-Restricted Eating for Mild Cognitive Impairment
Lexington, KentuckyThis study will investigate the feasibility of implementing a time-restricted eating intervention in females with mild cognitive impairment. Targeted therapeutic interventions that improve cognitive impairment and delay onset of ADRD are particularly important for females, who have twice the lifetime risk of developing AD, compared to males.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45 - 95
Sex:Female
Key Eligibility Criteria
Disqualifiers:Hypoglycemia, Liver Disease, Alcohol, Others
Must Not Be Taking:Eating Behavior Meds
15 Participants Needed
Benfotiamine for Alzheimer's Disease
Columbus, OhioThe purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer's disease.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50 - 89
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Diabetes, Cancer, Others
Must Be Taking:Acetylcholinesterase Inhibitors, Memantine
406 Participants Needed
BMS-986446 for Early Alzheimer's Disease
Dayton, OhioThis 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
Sensory Stimulation for Alzheimer's Disease
Columbus, OhioThis is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study.
Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:50 - 92
Sex:All
402 Participants Needed
ACU193 for Early Alzheimer's Disease
Lakewood, OhioThe primary purpose of this study is to evaluate the efficacy of sabirnetug infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:50 - 90
Sex:All
540 Participants Needed
Essential Fats for Cognitive Decline
Columbus, OhioThe proposed research is a randomized crossover trial designed to assess changes in postprandial cognitive function and the gut-brain axis in adults with subjective cognitive complaints who consume 1 study snack per day for 1 week.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Cancer, GI Diseases, Others
Must Not Be Taking:Diabetes Meds, Psychostimulants, Nootropics, Weight Loss Meds
88 Participants Needed
Novel Healthcare Approaches for Delirium in Elders
Pittsburg, PennsylvaniaThe goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following:
1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity.
2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes.
3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:70+
Sex:All
Key Eligibility Criteria
Disqualifiers:Delirium, Coma, Advanced Dementia, Others
3000 Participants Needed
The goal of this clinical trial is to test the effectiveness of a computerized anxiety sensitivity treatment (CAST) compared to a health education control (HEC) in older adults with mild cognitive impairment (MCI) or mild Alzheimer's Disease and related dementias (ADRD) and their care partners. The main questions it aims to answer are:
1. Efficacy of CAST in reducing anxiety and related symptoms among those with MCI/mild ADRD
2. Efficacy of CAST in reducing care partner burden among care partners of people living with MCI/mild ADRD
3. Explore treatment mechanisms using a multi-modal assessment battery of anxiety sensitivity and anxiety
Participants will complete six in-person visits including a baseline assessment, two intervention sessions, and three follow-up assessments at 1, 3, and 6-months posttreatment. Participants will also complete three weeks of ecological momentary assessments (EMAs) for one week prior to intervention, one week between intervention sessions, and one week after intervention.
If there is a comparison group: Researchers will compare CAST to HEC to see if CAST reduces anxiety and related symptoms in older adults with MCI/mild ADRD and care partner burden to a greater degree than HEC.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60+
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Mental Illness, Others
388 Participants Needed
Lifestyle Interventions for Mild Cognitive Impairment
Waterloo, OntarioThe objective of this study is to investigate the feasibility of a virtually-delivered 6-month exercise and nutrition intervention in older adults with executive subjective cognitive decline (SCD). Feasibility will be determined by recruitment, retention, and adherence rates. Preliminary changes in cognition, physical function, and quality of life will be assessed as secondary outcomes. The study will recruit 140 participants aged 65 to 80 who report they feel that their memory or other thinking abilities are declining. Participants will be randomized into one of four study arms receiving different combinations of healthy lifestyle interventions. Assessments will be conducted virtually at baseline, post-intervention (6 months), and follow-up (12 months). All intervention sessions and assessment visits will be conducted online using the Zoom Healthcare platform and participants will log on using their own devices from home.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:65 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Dementia, Stroke, Major Psychiatric Disorder, Others
140 Participants Needed
Combination Therapies + Lifestyle Modifications for Traumatic Brain Injury
Ann Arbor, MichiganThis trial tests if combining talking therapy, brain exercises, and lifestyle changes can help people with neurocognitive disorders live better lives by improving their thinking, brain function, and daily habits.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Depression, Substance Abuse, Others
Must Not Be Taking:Steroids
56 Participants Needed
Patient Priorities Care for Dementia
Indianapolis, IndianaThe goal of this pragmatic, embedded clinical trial is to analyze the implementation of Patient Priorities Care in primary care and geriatrics clinics with patients living with dementia or mild cognitive impairment. This study aims are:
* demonstrate the feasibility of using the electronic health record to identify a diverse cohort of eligible patient and patient-care partner dyads who will engage in a Patient Priorities Care conversation with a trained facilitator.
* demonstrate feasibility of pragmatically assessing clinical outcomes using the electronic health record, including a) number of days at home, b) total medications, and c) new referrals to specialist physicians.
* examine key feasibility measures across racial, ethnic, and socioeconomic subgroups.
Participants will receive a packet of information about Patient Priorities Care from their primary care clinic, in advance of their next upcoming clinic appointment. Individuals who receive a packet will have the opportunity to engage in a conversation about what matters most to them and what their priorities are, with trained facilitators at the clinic.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40+
Sex:All
160 Participants Needed
Precision Medicine for Dementia
Rocky River, OhioThe 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
Equol for Cognitive Impairment
Pittsburgh, PennsylvaniaThe ACE Trial, funded by the National Institute on Ageing/National Institutes of Health (NIH), is a multicenter clinical trial. The ACE Trial will determine if taking the dietary supplement Equol could slow the progression of stiffening of the arteries, small blood vessel disease in the brain and memory decline. Equol is a soy-based supplement that has plant estrogen-like compounds in it.
Equol is a metabolite of soy isoflavone. Our studies in Japan and other studies suggest that Equol may slow mechanisms related to memory decline. No previous studies in the United States have tested the effect of Equol on these mechanisms or memory decline. Supplementation of Equol in the ACE Trial is approved by the Food and Drug Administration (FDA).
Researchers at the University of Pittsburgh, Pittsburgh, Pennsylvania, Wake Forest University, Winston-Salem, North Carolina, and Emory University, Atlanta, Georgia, are recruiting participants.
The ACE Trial will ask participants to complete 7 clinic visits over a two-year period. The participants are asked to take Equol tablets daily for 24 months. Clinic procedures include Pulse Wave Velocity (to measure arterial stiffness), Magnetic Resonance Imaging (MRI) of the brain and tests of awareness and thinking.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:65 - 85
Sex:All
372 Participants Needed
Memory Training for Mild Cognitive Impairment
Ann Arbor, MichiganThe current study is a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in individuals with Mild Cognitive Impairment (MCI). Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with MCI and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to treat these cognitive deficits in order to improve the everyday functioning of individuals with MCI. Through a small randomized clinical trial, the investigators found that individuals with MCI with documented cognitive impairment show a significant improvement in their memory performance following a treatment protocol designed to facilitate learning. The current proposal will replicate this finding and further evaluate (a) the impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment and (c) the utility of booster sessions in facilitating long-term treatment effects. We will randomly assign older individuals who meet criteria for a diagnosis of amnestic MCI to a memory retraining group or a placebo control group. Both groups will undergo baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional neuropsychological battery, (2) an assessment of global functioning examining the impact of the treatment on daily activities, and (3) functional neuroimaging. This design will allow the investigators to evaluate the efficacy of this particular memory retraining technique in an aMCI population through the assessment of cognitive function via a standard evaluation. In addition, the investigators will be able to draw conclusions regarding the impact of this particular memory remediation program on everyday life from questionnaires completed by the participant and a significant other. Optional enrollment in pre- post neuroimaging will also allow the investigators to look at changes in the brain.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60+
Sex:All
Key Eligibility Criteria
Disqualifiers:Stroke, Bipolar, Schizophrenia, Others
Must Not Be Taking:Benzodiazepines, Steroids
120 Participants Needed
Virtual Reality + Cognitive Training for Mild Cognitive Impairment
Indianapolis, IndianaThis research project is relevant to public health because both heart failure (HF) and mild cognitive impairment (e.g., trouble remembering and concentrating beyond normal aging) are highly prevalent among older adults in the United States. Despite advances in health care, there are no effective interventions for treating cognitive impairment in HF, which if left untreated, leads to suboptimal health, quality of life, and shorter survival. Therefore, the investigators propose to test the effect of a dual-component intervention comprised of a virtual reality-based cognitive restoration intervention and computerized cognitive training on cognitive function and overall health among 172 older adults with HF who experience mild cognitive impairment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:55+
Sex:All
Key Eligibility Criteria
Disqualifiers:Advanced HF, Dementia, Schizophrenia, Others
172 Participants Needed
Biomarker Disclosure for Alzheimer's Disease
Ann Arbor, MichiganThe proposed project will assess long-term changes to health/lifestyle, advanced planning, and research engagement that Black and White patients with Amnestic Mild Cognitive Impairment (aMCI) make following disclosure of positron emission tomography-based amyloid and tau burden and associated risk of conversion to Dementia-Alzheimer's Type. Healthcare access will be explored as potential barrier to or facilitator of behavior change.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:50+
Sex:All
100 Participants Needed
Caffeine for Postoperative Delirium
Ann Arbor, MichiganThe objective of this study is to test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, this trial tests the primary hypothesis that caffeine will reduce the incidence of postoperative delirium.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:70+
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Cognitive Impairment, Seizure Disorder, Caffeine Intolerance, Others
250 Participants Needed
Sensory Stimulation for Alzheimer's Disease
Columbus, OhioThis trial is testing a device that uses light and sound to help patients with mild to moderate Alzheimer's disease. The goal is to see if this sensory stimulation can slow down the progression of the disease by improving brain function. This therapy has shown potential for application in the treatment of Alzheimer's disease.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Schizophrenia, Heart Disease, Others
Must Be Taking:Acetylcholinesterase Inhibitors
600 Participants Needed
BIIB080 for Alzheimer's Disease
Cincinnati, OhioIn 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
Remternetug for Alzheimer's Disease
Dayton, OhioThis trial tests remternetug, a drug given by injection or IV, in people with early Alzheimer's disease. It aims to find out if the drug is safe and can help improve symptoms or slow down the disease.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60 - 85
Sex:All
1667 Participants Needed
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Frequently Asked Questions
How much do Cognitive Impairment clinical trials 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 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 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 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 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 ?
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 ?
Most recently, we added Minocycline for Cognitive Decline in Sickle Cell Disease, Pramipexole vs Escitalopram for Depression in HIV and Varenicline for Parkinson's Disease to the Power online platform.
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