MedTrace Logo

Memory Improvement Through Nicotine Dosing (MIND) Study

NCT02720445 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2025-10-01

No results posted yet for this study

Summary

The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with MCI. Neuronal nicotinic receptors have long been known to play a critical role in memory function in preclinical studies, with nicotine improving attention, learning, and memory function.

The study will enroll 380 participants for a 2 year period. Participants will be randomized (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day, or placebo skin patch.

Conditions

Interventions

DRUG

Nicotine Transdermal Patch

21mg Nicotine transdermal patches worn 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.

DRUG

Placebo Patch

Matching placebo patches worn during waking hours.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Vanderbilt University

    collaborator OTHER

  • Alzheimer's Therapeutic Research Institute

    collaborator OTHER

  • University of Southern California

    lead OTHER

Principal Investigators

  • Paul Aisen, MD · USC Alzheimer's Therapeutic Research Institute (ATRI)

  • Paul Newhouse, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-13
Primary Completion
2025-08-25
Completion
2025-09-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02720445 on ClinicalTrials.gov