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Nicotine patch trial aims to boost memory in seniors

NCT ID NCT02720445

Disease control Sponsor: University of Southern California Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tested whether daily nicotine patches could improve memory and daily function in 348 people with mild cognitive impairment (MCI). Participants wore either a nicotine patch (up to 21 mg) or a placebo patch for two years. The goal was to see if nicotine, known to affect brain receptors linked to memory, could help slow or improve thinking problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nicotine transdermal patch
What this could lead to
If it works, this could point toward a treatment that slows memory decline in people with mild cognitive impairment.
What could go wrong
This is a Phase 2 trial with moderate size, so results are not definitive. Nicotine can be addictive and may cause side effects like skin irritation or sleep problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

348 people

The number who actually took part.

Started

Feb 2017

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant must have a subjective memory concern as reported by participant, study partner, or clinician 2. 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 3. Mini-Mental State Exam score between 24 and 30, inclusive 4. Clinical Dementia Rating (CDR) Global = 0.5. Memory Box score must be at least 0.5 5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease dementia cannot be made by the site physician at the time of the screening visit 6. Age 55-90 (inclusive) 7. Stable permitted medications for 4 weeks or longer as specified in Section 6, including: • Memantine and cholinesterase inhibitors are allowable if stable for 12 weeks prior to screen 8. Geriatric Depression Scale score of less than or equal to 14 9. Study Partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to most visits to answer questions about the participant 10. Adequate visual and auditory acuity to allow neuropsychological testing 11. Good general health with no additional diseases/disorders expected to interfere with the study 12. Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile) 13. Completed six grades of education or has a good work history 14. Fluent in English or Spanish Exclusion Criteria: 1. Regular use of tobacco products within the past year, such as smoking (cigarettes, pipes, cigars, etc.) or use of other nicotine products (chewing tobacco, e-cigarettes, nicotine patches, gum, sprays, etc.). 2. Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. 3. Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol 4. History of schizophrenia (DSM V criteria) 5. History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria) 6. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results, or the participant's ability to participate in the study. 7. Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment 8. Clinically significant abnormalities in B12 or TFTs (Thyroid Function Tests) that might interfere with the study. A low B12 is exclusionary, unless the required follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. 9. Clinically significant abnormalities in screening laboratories or ECG. 10. Residence in skilled nursing facility. 11. Use of any excluded medication as described in the protocol, including: * Use of centrally acting anti-cholinergic drugs * Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening. 12. For CSF sub-study participants, a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT (partial thromboplastin time) at screening 13. For MRI sub-study participants, contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker. 14. Patients whom the Site PI deems to be otherwise ineligible.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mild cognitive impairment

Contacts and locations

Locations

  • Augusta University Movement and Memory Disorders

    Augusta, Georgia, 30912, United States

  • Brain Matters Research

    Delray Beach, Florida, 33445, United States

  • Brain Matters Research

    Stuart, Florida, 34997, United States

  • Central Arkansas Veterans Healthcare System

    North Little Rock, Arkansas, 72205, United States

  • Central States Research (formerly Tulsa Clinical Research)

    Tulsa, Oklahoma, 74104, United States

  • Georgetown University

    Washington D.C., District of Columbia, 200072145, United States

  • Glenn Biggs Institute at the University of Texas Health

    San Antonio, Texas, 78229, United States

  • Headlands Eastern MA LLC

    Plymouth, Massachusetts, 02360, United States

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030, United States

  • Integrative Clinical Trials

    New York, New York, 11229, United States

  • JEM Research Institute

    Atlantis, Florida, 33462, United States

  • Kingfisher Cooperative, LLC

    Spokane, Washington, 99202, United States

  • LeHigh Valley Hospital

    Allentown, Pennsylvania, 18105, United States

  • Miami Jewish Health Systems

    Miami, Florida, 33137, United States

  • Mount Sinai School of Medicine

    New York, New York, 100296552, United States

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018, United States

  • New York University Medical Center

    New York, New York, 100166055, United States

  • Northwestern University

    Chicago, Illinois, 606113010, United States

  • Nuvance Health Medical Practice Ct, Inc.; Associated Neurologists, PC

    Danbury, Connecticut, 06810, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Perseverance Research Center

    Scottsdale, Arizona, 85254, United States

  • Providence Brain and Spine Institute

    Portland, Oregon, 97225, United States

  • Ralph H. Johnson VA Health Care System

    Charleston, South Carolina, 294011113, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Sharp Neurocognitive Research Center

    San Diego, California, 92123, United States

  • Syrentis Clinical Research

    Santa Ana, California, 92705, United States

  • USC Rancho Los Amigos

    Downey, California, 90242, United States

  • University at Buffalo (UBMD)

    Buffalo, New York, 14203, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Washington Memory and Brain Wellness Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    Madison, Wisconsin, 53706, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research - Syracuse

    East Syracuse, New York, 13057, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

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