Memory Improvement Through Nicotine Dosing (MIND)

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?

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

 

Who Is the General Study Contact?

For more information and to enroll, visit the MIND study website or email ATRI Recruitment.

Where Is This Study Located?

Arkansas
Central Arkansas Veterans HS North Little Rock, AR 72205 Recruiting
Sharp Neurocognitive Research Center San Diego, CA 92123 Recruiting
Syrentis Clinical Research Santa Ana, CA 92705 Recruiting
Connecticut
Nuvance Health Medical Practice Ct, Inc.; Associated Neurologists, PC Danbury, CT 06810 Recruiting
District of Columbia
Georgetown University Washington, DC 200072145 Recruiting
Florida
JEM Research Institute Atlantis, FL 33462 Recruiting
Brain Matters Research - Delray Beach Delray Beach, FL 33445 Recruiting
Miami Jewish Health Systems Miami, FL 33137 Recruiting
Brain Matters Research - Stuart Stuart, FL 34997 Recruiting
Georgia
Augusta University Augusta, GA 30912 Recruiting
Idaho
Velocity Clinical Research Meridian, ID 83642 Recruiting
Illinois
Northwestern University Chicago, IL 606113010 Recruiting
Iowa
University of Iowa Iowa City, IA 52242 Recruiting
Massachusetts
Donald S. Marks Plymouth, MA 02360 Recruiting
New York
University of Buffalo (UBMD Neurology) Buffalo, NY 14203 Recruiting
Velocity Clinical Research East Syracuse, NY 13057 Recruiting
New York University Medical Center New York, NY 100166055 Recruiting
Mount Sinai School of Medicine New York, NY 10029-6552 Recruiting
Integrative Clinical Trials New York, NY 11229 Recruiting
SUNY-Upstate Medical Center Syracuse, NY 13210 Recruiting
Ohio
Ohio State University Columbus, OH 43210 Recruiting
Oklahoma
Central States Research Tulsa, OK 74104 Recruiting
Oregon
Providence Brain and Spine Institute Portland, OR 97225 Recruiting
Penn State Hershey Medical Center Hershey, PA 17033 Recruiting
South Carolina
Ralph H. Johnson VA Medical Center Charleston, SC 29401 Recruiting
Tennessee
Neurology Clinic, P.C. Cordova, TN 38018 Recruiting
Vanderbilt University Medical College Nashville, TN 37212 Recruiting
Texas
Houston Methodist Neurological Institute Houston, TX 77030 Recruiting
Glenn Biggs Institute at the University of Texas Health San Antonio, TX 78229 Recruiting
Utah
University of Utah Salt Lake City, UT 84112 Recruiting
Kingfisher Cooperative, LLC Spokane, WA 99202 Recruiting
Wisconsin
University of Wisconsin Madison, WI 53706 Recruiting

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