NCT02720445

Memory Improvement Through Nicotine Dosing (MIND) Study

Long-Term Nicotine Treatment of Mild Cognitive Impairment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Nicotine Transdermal Patch	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.
DRUG	Placebo Patch	Matching placebo patches worn during waking hours.

Timeline

• Start date: 2017-01-13
• Primary completion: 2025-08-25
• Completion: 2025-09-16
• First posted: 2016-03-25
• Last updated: 2025-10-01

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study