Nicotine Patch for Mild Cognitive Impairment (MIND Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Southern California

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults aged 55-90 with mild cognitive impairment, who are not pregnant or at risk of becoming pregnant, and have a reliable study partner. Participants should be in good health without serious diseases that could affect the study, not use tobacco products for the past year, and must not have Alzheimer's disease or other significant neurological conditions.

Inclusion Criteria

I, or someone close to me, have noticed memory problems.

Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised: less than or equal to 11 for 16 or more years of education, less than or equal to 9 for 8 - 15 years of education, less than or equal to 6 for 0 - 7 years of education

Mini-Mental State Exam score between 24 and 30, inclusive

Clinical Dementia Rating (CDR) Global = 0.5. Memory Box score must be at least 0.5

I am between 55 and 90 years old.

My medications, including for memory issues, have been stable for at least 4 weeks.

Treatment Details

The MIND Study is testing if nicotine patches can improve memory and cognitive function in people with mild cognitive impairment over two years. Half will receive nicotine starting at 7mg/day up to 21mg/day; the other half will get placebo patches.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nicotine Transdermal PatchExperimental Treatment1 Intervention

190 participants will wear nicotine transdermal patches 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

Group II: Placebo PatchPlacebo Group1 Intervention

190 participants will wear matching placebo patches during waking hours.