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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

Awards & highlights

MIND Trial 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.Check my eligibility

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.See study design

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.

MIND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I, or someone close to me, have noticed memory problems.

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I am between 55 and 90 years old.

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My medications, including for memory issues, have been stable for at least 4 weeks.

MIND Trial Timeline

Screening ~ 28 days1 visit

Treatment ~ 26 weeks13 visits

Follow Up ~ 30 days1 visit

Screening ~ 28 days

Treatment ~ 26 weeks

Follow Up ~30 days

This trial's timeline: 28 days for screening, 26 weeks for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline of the Conners Continuous Performance Task (CPT) to Month 25

Secondary outcome measures

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 more

Other outcome measures

Cerebrospinal Fluid

Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Month 25

Side effects data

From 2016 Phase 4 trial • 36 Patients • NCT02681510

75%

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

Angina

100%

80%

60%

40%

20%

Study treatment Arm

Three Drug Intervention

MIND 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

0 / 6Eligibility criteria met

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

905 Previous Clinical Trials

1,595,938 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,668 Previous Clinical Trials

28,004,684 Total Patients Enrolled

Vanderbilt UniversityOTHER

703 Previous Clinical Trials

6,142,967 Total Patients Enrolled

Media Library

Nicotine Transdermal Patch (Nicotinic Acetylcholine Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02720445 — Phase 2

Mild Cognitive Impairment Clinical Trial 2023: Nicotine Transdermal Patch Highlights & Side Effects. Trial Name: NCT02720445 — Phase 2

Nicotine Transdermal Patch (Nicotinic Acetylcholine Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02720445 — Phase 2

Mild Cognitive Impairment Research Study Groups: Nicotine Transdermal Patch, Placebo Patch

Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT02720445 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in this clinical research?

"This clinical experiment requires 380 participants that satisfy all outlined inclusion criteria. Potential test subjects may join this trial at Syrentis Clinical Research in Santa Ana, California or SUNY Upstate Medical University in Syracuse, New york, among other medical centres."

Answered by AI

Does this clinical research have vacancies available for participants?

"According to the records on clinicaltrials.gov, this trial is actively seeking out participants and has been since it was initially posted in January of 2017. The most recent update took place in November 2022."

Answered by AI

How widely spread is the implementation of this trial?

"This clinical trial is presently enrolling participants from a total of 34 sites, including Santa Ana, Syracuse and Augusta. It's beneficial to look up the clinic closest to you in order reduce travel costs should you decide to join."

Answered by AI

Am I eligible to enrol in this experiment?

"This trial seeks 380 participants between 55 and 90 years old who suffer from mild cognitive impairment (MCI). Eligibility criteria include a self-reported, partner reported, or clinician identified memory concern of 11 or less for those with 16+ education years; 9 or lower for 8-15 educational years; 6 or under for 0-7 educational years. Additionally, candidates must have an MMSE score between 24 and 30 inclusive, CDR Global Score =0.5, Memory Box Score ≥ 0.5 , no diagnosis of Alzheimer's dementia at screening visit by the physician onsite, stable Memantine/Cholinesterase"

Answered by AI

Is utilizing a Nicotine Transdermal Patch sufficiently safe for general public use?

"The safety rating for the Nicotine Transdermal Patch received a score of 2 due to the Phase 2 trial data suggesting some degree of security, albeit without any efficacy records."

Answered by AI

Does this study accept participants who have exceeded the age of 35?

"As indicated in this clinical trial's selection standards, the minimum age for enrollment is 55 years old and participants must be below 90."

Answered by AI

What additional studies have been conducted involving the utilization of Nicotine Transdermal Patch?

"In 2006, research conducted at The University of Hong Kong first investigated the effects of nicotine transdermal patches. Since then, 423 completed studies have been reported, with 71 still ongoing - particularly in Santa Ana."

Answered by AI