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 Mild Cognitive Impairment (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 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.
Inclusion Criteria:
Subject must have a subjective memory concern
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
Age 55-90 (inclusive)
Stable permitted medications for 4 weeks or longer (memantine is allowable if stable for 12 weeks prior to screen)
Study partner is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), and can accompany the subject to most visits to answer questions about the subject
Adequate visual and auditory acuity to allow neuropsychological testing
Good general health with no additional diseases/disorders expected to interfere with the study
Completed six grades of education or has a good work history
Must speak English fluently
Exclusion Criteria:
Regular use of tobacco produce within the past year, such as smoking (cigarettes, pipes, cigars, etc.) or use of other nicotine products (chewing tobacco, e-cigarettes, nicotine patches, gum, sprays, etc.)
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
Major depression, bipolar disorder within the past year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol
History of schizophrenia
History of alcohol or substance abuse or dependence within the past 2 years
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 subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study
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