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 5 weeks of treatment, remain at 21mg up to month 24, and then taper down for three weeks.
Matching placebo patches worn during waking hours.
Cogstate Battery International Shopping List Test - Total Immediate Recall (ISLT-TIR)
The ISLT - TIR represents the number of correct responses made when remembering the twelve word shopping list on three consecutive trials. The unit of the variable is correct responses count and higher score is better performance. Scores range from 0 to 36.
Time frame: From Baseline to month 24
Change From Baseline in Mild Cognitive Impairment - Clinical Global Impression of Change (MCI-CGIC) to Month 24
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: From Baseline to month 24
International Shopping List Test - Delayed Recall (ISRL)
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: From Baseline to month 24
Identification Task
The IDN evaluates attention and is assessed in speed of performance. Lower score is better performance.
Time frame: From Baseline to month 24
One Card Learning Task (OCL)
The OCL evaluates visual learning and is assessed in accuracy of performance; performance; arcsine square root proportion correct. Higher score is better performance. Ranges from 0 to 1.5708
Time frame: From Baseline to month 24
Detection Task
The DET evaluates Psychomotor Function and is assessed in speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score is better performance, ranges from 2.001 to 6.
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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: From Baseline to month 24
One Back Task (ONB)
The ONB evaluates working memory and is assessed in speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score is better performance, ranges from ranges from 2.001 to 6.
Time frame: From Baseline to month 24
NYU Immediate Recall (NYU-Immediate)
The NYU-Immediate recall evaluates immediate verbal recall. Higher is better performance
Time frame: From Baseline to month 24
NYU Delayed Recall (NYU-DELAY)
The NY-DELAY evaluates delayed verbal recall. Higher is better performance
Time frame: From Baseline to month 24
Clinical Dementia Rating Scale (CDR) - Sum of Boxes (SOB)
The is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe.
Time frame: From Baseline to month 24
Geriatric Depression Scale (GDS)
The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".
Time frame: Month 24
Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
This scale is an inventory developed to assess functional performance in participantss with Alzheimer's disease.
Time frame: From Baseline to month 24