Memory Improvement Through Nicotine Dosing (MIND) Study
NCT ID: NCT02720445
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
348 participants
INTERVENTIONAL
2017-01-13
2025-09-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nicotine Transdermal Patch
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
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.
Placebo Patch
190 participants will wear matching placebo patches during waking hours.
Placebo Patch
Matching placebo patches worn during waking hours.
Interventions
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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.
Placebo Patch
Matching placebo patches worn during waking hours.
Eligibility Criteria
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Inclusion Criteria
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
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.
55 Years
90 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Vanderbilt University
OTHER
Alzheimer's Therapeutic Research Institute
OTHER
University of Southern California
OTHER
Responsible Party
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Paul S. Aisen
Professor
Principal Investigators
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Paul Aisen, MD
Role: STUDY_DIRECTOR
USC Alzheimer's Therapeutic Research Institute (ATRI)
Paul Newhouse, MD
Role: STUDY_DIRECTOR
Vanderbilt University
Locations
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Perseverance Research Center
Scottsdale, Arizona, United States
Central Arkansas Veterans Healthcare System
North Little Rock, Arkansas, United States
USC Rancho Los Amigos
Downey, California, United States
Sharp Neurocognitive Research Center
San Diego, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Nuvance Health Medical Practice Ct, Inc.; Associated Neurologists, PC
Danbury, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
JEM Research Institute
Atlantis, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Brain Matters Research
Stuart, Florida, United States
Augusta University Movement and Memory Disorders
Augusta, Georgia, United States
Velocity Clinical Research - Boise
Meridian, Idaho, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Headlands Eastern MA LLC
Plymouth, Massachusetts, United States
University at Buffalo (UBMD)
Buffalo, New York, United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, United States
New York University Medical Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Integrative Clinical Trials
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Central States Research (formerly Tulsa Clinical Research)
Tulsa, Oklahoma, United States
Providence Brain and Spine Institute
Portland, Oregon, United States
LeHigh Valley Hospital
Allentown, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
Glenn Biggs Institute at the University of Texas Health
San Antonio, Texas, United States
University of Washington Memory and Brain Wellness Center
Seattle, Washington, United States
Kingfisher Cooperative, LLC
Spokane, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Newhouse PA, Potter A, Corwin J, Lenox R. Age-related effects of the nicotinic antagonist mecamylamine on cognition and behavior. Neuropsychopharmacology. 1994 Apr;10(2):93-107. doi: 10.1038/npp.1994.11.
Newhouse P, Kellar K, Aisen P, White H, Wesnes K, Coderre E, Pfaff A, Wilkins H, Howard D, Levin ED. Nicotine treatment of mild cognitive impairment: a 6-month double-blind pilot clinical trial. Neurology. 2012 Jan 10;78(2):91-101. doi: 10.1212/WNL.0b013e31823efcbb.
Dumas J, Hancur-Bucci C, Naylor M, Sites C, Newhouse P. Estrogen treatment effects on anticholinergic-induced cognitive dysfunction in normal postmenopausal women. Neuropsychopharmacology. 2006 Sep;31(9):2065-78. doi: 10.1038/sj.npp.1301042. Epub 2006 Feb 15.
Newhouse PA, Dumas J, Hancur-Bucci C, Naylor M, Sites CK, Benkelfat C, Young SN. Estrogen administration negatively alters mood following monoaminergic depletion and psychosocial stress in postmenopausal women. Neuropsychopharmacology. 2008 Jun;33(7):1514-27. doi: 10.1038/sj.npp.1301530. Epub 2007 Aug 15.
Newhouse PA, Sunderland T, Tariot PN, Blumhardt CL, Weingartner H, Mellow A, Murphy DL. Intravenous nicotine in Alzheimer's disease: a pilot study. Psychopharmacology (Berl). 1988;95(2):171-5. doi: 10.1007/BF00174504.
Joe E, Ringman JM. Cognitive symptoms of Alzheimer's disease: clinical management and prevention. BMJ. 2019 Dec 6;367:l6217. doi: 10.1136/bmj.l6217.
Related Links
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Alzheimer's Therapeutic Research Institute (ATRI). ATRI is the Coordinating Center for the MIND study.
MIND study public website
Other Identifiers
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131918
Identifier Type: OTHER
Identifier Source: secondary_id
ATRI-002-NIC
Identifier Type: -
Identifier Source: org_study_id
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