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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
348
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.
Matching placebo patches worn during waking hours.
Cogstate Battery International Shopping List Test - Total Immediate Recall (ISLT-TIR)
Time frame: 2 years
Change from Baseline in Mild Cognitive Impairment - Clinical Global Impression of Change (MCI-CGIC) to Month 25
The MCI-CGIC is the MCI version of the clinician's global impression of change. In this trial it will measure change in the participant's condition between the baseline visit and subsequent visits.
Time frame: 2 years
Change from Baseline in Cogstate Brief Battery (CBB) to Month 25
This battery will be used for the purpose of assessing the cognitive status of the participants and will assist in documenting multiple domains of cognitive impairment.
Time frame: 2 years
Change in Baseline in New York University (NYU) Paragraph Recall to Month 25
This test measures immediate and delayed verbal recall of a brief story.
Time frame: 2 years
Change from Baseline in Clinical Dementia Rating Scale (CDR) - Sum of Boxes (SOB) to Month 25
The is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe.
Time frame: 2 years
Change in Baseline in Geriatric Depression Scale (GDS) to Month 25
This is a 30-item self-report assessment used to identify depression in the elderly.
Time frame: 2 years
Change in Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) to Month 25
This scale is an inventory developed to assess functional performance in participantss with Alzheimer's disease.
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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
...and 26 more locations
Time frame: 2 years
Change from Baseline in Older Adult Self Report (OASR) / Older Adult Behavior Checklist (OABCL) to Month 25
The OASR/OABCL is a general index of psychopathologic symptoms and signs that is specifically relevant to elderly individuals and is developmentally appropriate, covers a wide range of psychopathologic signs and symptoms, and functional measures. It allows multi-informant perspective (both patient and informant). The items are focused on common elderly emotional, functional, or medical problems. The OASR is completed by the participant and the companion OABCL is completed by the informant.
Time frame: 2 years