Your session is about to expire
← Back to Search
Nicotinic Acetylcholine Receptor Agonist
Nicotine Patch for Mild Cognitive Impairment (MIND Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must have a subjective memory concern as reported by participant, study partner, or clinician
Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised: less than or equal to 11 for 16 or more years of education, less than or equal to 9 for 8 - 15 years of education, less than or equal to 6 for 0 - 7 years of education
Timeline
Screening 28 days
Treatment 26 weeks
Follow Up 30 days
Summary
This trial will test if daily transdermal nicotine can improve cognitive, clinical, and functional outcomes in people with mild cognitive impairment.
Who is the study for?
Adults aged 55-90 with mild cognitive impairment, who are not pregnant or at risk of becoming pregnant, and have a reliable study partner. Participants should be in good health without serious diseases that could affect the study, not use tobacco products for the past year, and must not have Alzheimer's disease or other significant neurological conditions.
What is being tested?
The MIND Study is testing if nicotine patches can improve memory and cognitive function in people with mild cognitive impairment over two years. Half will receive nicotine starting at 7mg/day up to 21mg/day; the other half will get placebo patches.
What are the potential side effects?
Nicotine patches may cause skin irritation where applied, dizziness, headache, nausea, increased heart rate or blood pressure. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I, or someone close to me, have noticed memory problems.
Select...
I am between 55 and 90 years old.
Select...
My medications, including for memory issues, have been stable for at least 4 weeks.
Timeline
Screening ~ 28 days1 visit
Treatment ~ 26 weeks13 visits
Follow Up ~ 30 days1 visit
Screening ~ 28 days
Treatment ~ 26 weeks
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline of the Conners Continuous Performance Task (CPT) to Month 25
Secondary study objectives
Change from Baseline in Clinical Dementia Rating Scale (CDR) - Sum of Boxes (SOB) to Month 25
Change from Baseline in Cogstate Brief Battery (CBB) to Month 25
Change from Baseline in Mild Cognitive Impairment - Clinical Global Impression of Change (MCI-CGIC) to Month 25
+4 moreOther study objectives
Cerebrospinal Fluid
Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Month 25
Side effects data
From 2016 Phase 4 trial • 36 Patients • NCT0268151075%
Insomnia
72%
Vivid Dreams
64%
Nausea
42%
Mood Changes
39%
Dizziness
19%
Skin Rash
19%
Sweating
14%
Shortness of Breath
14%
Vomiting
11%
Chest Tightness
3%
Angina
100%
80%
60%
40%
20%
0%
Study treatment Arm
Three Drug Intervention
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotine Transdermal PatchExperimental Treatment1 Intervention
190 participants will wear nicotine transdermal patches during waking hours. Active dose will titrate up from 3.5mg to 21mg in the first 6 weeks of treatment, remain at 21mg for 22.5 months, and then taper down in the final month of treatment
Group II: Placebo PatchPlacebo Group1 Intervention
190 participants will wear matching placebo patches during waking hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Transdermal Patch
2016
Completed Phase 4
~190
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,265 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,787 Previous Clinical Trials
28,184,408 Total Patients Enrolled
Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,142,999 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your score on the Geriatric Depression Scale is 14 or higher.My B12 levels are normal or, if low, follow-up tests show no significant issues.I can see and hear well enough for brain function tests.My medications, including for memory issues, have been stable for at least 4 weeks.You have no signs of Alzheimer's disease or other cognitive impairments during the screening visit.You have experienced severe depression, bipolar disorder or other mental health conditions in the past year that could make it hard for you to follow the study plan.I have not had cancer in the past 5 years, except for certain skin or early stage cancers.I haven't taken any excluded medications, including certain brain-acting drugs or new investigational drugs recently.I, or someone close to me, have noticed memory problems.My education level is 16 years or more with a score of 11 or less.My education level is 7 years or less.You have been diagnosed with schizophrenia according to the DSM V criteria.I do not have major neurological conditions like Alzheimer's, Parkinson's, or MS.I, or someone close to me, have noticed memory problems.I am not pregnant, breastfeeding, and cannot become pregnant.I have someone who can join me for visits and knows about my daily activities.I am fluent in either English or Spanish.I am in good health with no other conditions that could affect the study.My education level is between 8 and 15 years.I am between 55 and 90 years old.I have used tobacco or nicotine products in the last year.You have had problems with alcohol or drug abuse in the past 2 years, as defined by medical guidelines.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 28 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 26 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 30 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Nicotine Transdermal Patch
- Group 2: Placebo Patch
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT02720445 — Phase 2
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger