Nicotine Patch for Mild Cognitive Impairment

(MIND Trial)

Recruiting at 44 trial locations

Overseen By Raymond Scott Turner

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Southern California

Must be taking: Memantine, Cholinesterase inhibitors

Must not be taking: Centrally acting anticholinergics

Disqualifiers: Tobacco use, Neurologic disease, Major depression, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

380 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that any medications you are taking must be stable for at least 4 weeks before joining, and certain medications like memantine and cholinesterase inhibitors must be stable for 12 weeks. Some medications, like centrally acting anti-cholinergic drugs, are not allowed.

What data supports the effectiveness of the nicotine patch treatment for mild cognitive impairment?

Research shows that using a nicotine patch for 6 months can improve cognitive performance in people with mild cognitive impairment. Additionally, nicotine has been found to enhance attention and reaction time in Alzheimer's patients, suggesting it may help with similar cognitive issues. ^{1 2 3 4 5}

Is the nicotine patch safe for humans?

Research shows that nicotine patches are generally safe for humans, as they deliver controlled doses of nicotine without the harmful effects of smoking. In studies, most participants tolerated the patches well, even at higher doses, although some experienced mild side effects. ^{1 3 4 5 6}

How does the nicotine patch treatment for mild cognitive impairment differ from other treatments?

The nicotine patch is unique for mild cognitive impairment because it is a transdermal (through the skin) treatment that may improve cognitive performance by targeting nicotinic acetylcholine receptors in the brain, unlike other treatments that are not FDA-approved for this condition. ^{1 3 4 5 7}

Research Team

Paul Aisen, MD

Principal Investigator

USC Alzheimer's Therapeutic Research Institute (ATRI)

Paul Newhouse, MD

Principal Investigator

Vanderbilt University

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

Your score on the Geriatric Depression Scale is 14 or higher.

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

Exclusion Criteria

For CSF sub-study participants, a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT (partial thromboplastin time) at screening

My B12 levels are normal or, if low, follow-up tests show no significant issues.

For MRI sub-study participants, contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transdermal nicotine or placebo patches, with nicotine doses titrating up from 3.5mg to 21mg in the first 6 weeks, remaining at 21mg for 22.5 months, and tapering down in the final month

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nicotine Transdermal Patch
• Placebo Patch

Trial Overview 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.

Participant Groups

Group I: Nicotine Transdermal Patch Experimental Treatment 1 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 Patch Placebo Group 1 Intervention

190 participants will wear matching placebo patches during waking hours.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Alzheimer's Therapeutic Research Institute

Collaborator

Trials

18

Recruited

58,400+

Findings from Research

A 6-month pilot clinical trial demonstrated that transdermal nicotine treatment improved cognitive performance in individuals with amnestic mild cognitive impairment (MCI), suggesting a potential new treatment avenue for this condition.

Currently, there are no FDA-approved medications for MCI, highlighting the importance of this study in exploring nicotine as a viable option for improving cognitive function in affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible role of nicotine for the treatment of mild cognitive impairment. Roh, S., Evins, AE.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nicotine treatment of mild cognitive impairment: a 6-month double-blind pilot clinical trial. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of acute subcutaneous nicotine on attention, information processing and short-term memory in Alzheimer's disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Possible role of nicotine for the treatment of mild cognitive impairment. [2012]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The effects of nicotine in dermal plaster on cognitive functions in patients with Alzheimer's disease. [2019]

5. Denmark pubmed.ncbi.nlm.nih.gov

Effects of transdermal nicotine delivery on cognitive outcomes: A meta-analysis. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Nicotinic treatment for cognitive dysfunction. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of transdermal nicotine on prose memory and attention in smokers and nonsmokers. [2015]