Memory Improvement Through Nicotine Dosing (MIND)
Start: January 2017
End: July 2023
Enrollment: 300
What Is This Study About?
Nicotine has been shown to improve attention, learning, and memory. In this trial, researchers will test whether nicotine delivered via a transdermal (skin) patch improves memory performance in older adults who are have mild cognitive impairment. Participants will be randomly assigned to wear either a nicotine skin patch or a placebo for two years during waking hours. Researchers will measure changes in attention, cognitive impairment, memory, mood, and other daily tasks. They will also look for changes in biomarkers in cerebrospinal fluid and on brain imaging of some participants.
Do I Qualify To Participate in This Study?
Minimum Age: 55 Years
Maximum Age: 90 Years
Must have:
- Subjective memory concern reported by participant, study partner, or doctor
- Abnormal memory function
- Mini-Mental State Examination score of 24-30
- Clinical Dementia Rating of 0.5 (very mild dementia)
- General cognition and functional performance such that a diagnosis of Alzheimer's cannot be made
- Medications stable for at least four weeks; memantine (Namenda) is allowed if stable for at least 12 weeks
- Geriatric Depression Scale score of 9 or less
- Study partner who has contact on average 10 or more hours per week and can attend most visits
- Adequate visual and auditory ability to allow neuropsychological testing
- Good general health with no diseases, disorders, or significant abnormalities that could interfere with the study
- If female, must be two years postmenopausal or surgically sterile
- Completed six grades of education or has a good work history
- Fluent in English
Must NOT have:
- Regular use of tobacco products within the past year, including cigarettes, pipes, cigars, chewing tobacco, e-cigarettes, nicotine patches, gum, and sprays
- Any significant neurologic disease, such as Alzheimer's, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis
- History of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities
- Major depression; bipolar disorder within the past year; or psychotic features, agitation, or behavioral problems within past three months
- History of schizophrenia
- History of alcohol or substance abuse or dependence within the past two years
- Significant or unstable medical condition, including uncontrolled hypertension or diabetes, or significant heart, lung, kidney, liver, endocrine, or other systemic disease
- History within the last five 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
- Significant abnormalities in B12 or thyroid function tests that might interfere with the study
- Significant abnormalities in screening laboratories or electrocardiogram
- Residence in skilled nursing facility
- Use of centrally acting anti-cholinergic drugs, such as donepezil (Aricept) and rivastigmine (Exelon), or other excluded medications
- Use of any investigational drugs within 30 days or five half-lives, whichever is longer
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Who Is the General Study Contact?
For more information about the MIND study or study sites, visit www.mindstudy.org or contact ATRI Recruitment at mind-participate@usc.edu.
Study Contact
ATRI Recruitment
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
| Arkansas | |
|---|---|
|
Central Arkansas Veterans HS
North Little Rock, AR 72205
Recruiting
Kalpana Padala |
|
|
Sharp Neurocognitive Research Center
San Diego, CA 92123
Recruiting
Sofia Menendez |
|
|
Syrentis Clinical Research
Santa Ana, CA 92705
Recruiting
Lorrie Bisesi |
|
| Connecticut | |
|
Nuvance Health Medical Practice Ct, Inc.; Associated Neurologists, PC
Danbury, CT 06810
Recruiting
Dawn Morsey |
|
| District of Columbia | |
|
Georgetown University
Washington, DC 200072145
Recruiting
Jessica Mallory |
|
| Florida | |
|
JEM Research Institute
Atlantis, FL 33462
Recruiting
Belinda Russell |
|
|
Brain Matters Research - Delray Beach
Delray Beach, FL 33445
Recruiting
Ystha Alonso |
|
|
Miami Jewish Health Systems
Miami, FL 33137
Recruiting
Myriam Vazquez Ramos |
|
|
Brain Matters Research - Stuart
Stuart, FL 34997
Recruiting
Ystha Alonso |
|
| Georgia | |
|
Augusta University
Augusta, GA 30912
Recruiting
Paula Jackson |
|
| Idaho | |
|
Velocity Clinical Research
Meridian, ID 83642
Recruiting
Audra Weslowski |
|
| Illinois | |
|
Northwestern University
Chicago, IL 606113010
Recruiting
Brittanie Muse |
|
| Iowa | |
|
University of Iowa
Iowa City, IA 52242
Recruiting
Karen Ekstam-Smith |
|
| Massachusetts | |
|
Donald S. Marks
Plymouth, MA 02360
Recruiting
Erin Kearney |
|
| New York | |
|
University of Buffalo (UBMD Neurology)
Buffalo, NY 14203
Recruiting
Natalie Argueta |
|
|
Velocity Clinical Research
East Syracuse, NY 13057
Recruiting
Christine Hall |
|
|
New York University Medical Center
New York, NY 100166055
Recruiting
Anaztasia Ulysse |
|
|
Mount Sinai School of Medicine
New York, NY 10029-6552
Recruiting
Alexandra Groome |
|
|
Integrative Clinical Trials
New York, NY 11229
Recruiting
Khatuna Tsotsoria |
|
|
SUNY-Upstate Medical Center
Syracuse, NY 13210
Recruiting
Colleen Dillenbeck |
|
| Ohio | |
|
Ohio State University
Columbus, OH 43210
Recruiting
Jennifer Icenhour |
|
| Oklahoma | |
|
Central States Research
Tulsa, OK 74104
Recruiting
Christy Lisenbee |
|
| Oregon | |
|
Providence Brain and Spine Institute
Portland, OR 97225
Recruiting
Lynette Currie |
|
|
Penn State Hershey Medical Center
Hershey, PA 17033
Recruiting
Leonard Kishel |
|
| South Carolina | |
|
Ralph H. Johnson VA Medical Center
Charleston, SC 29401
Recruiting
Rebecca Long |
|
| Tennessee | |
|
Neurology Clinic, P.C.
Cordova, TN 38018
Recruiting
Rebecca Sparks |
|
|
Vanderbilt University Medical College
Nashville, TN 37212
Recruiting
Amy Boegel |
|
| Texas | |
|
Houston Methodist Neurological Institute
Houston, TX 77030
Recruiting
Jennifer Garrett |
|
|
Glenn Biggs Institute at the University of Texas Health
San Antonio, TX 78229
Recruiting
Amy Saklad |
|
| Utah | |
|
University of Utah
Salt Lake City, UT 84112
Recruiting
Brian Farstead |
|
|
Kingfisher Cooperative, LLC
Spokane, WA 99202
Recruiting
Kasey Hunter |
|
| Wisconsin | |
|
University of Wisconsin
Madison, WI 53706
Recruiting
Yanmin Li |
|
Who Sponsors This Study?
Lead: University of Southern California
Collaborator Sponsor
- National Institute on Aging (NIA)
- Vanderbilt University
- Alzheimer's Therapeutic Research Institute
Source: ClinicalTrials.gov ID: NCT02720445