Nicotine Patch for Mild Cognitive Impairment

(MIND Trial)

No longer recruiting at 45 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a nicotine patch can improve memory and daily functioning in people with Mild Cognitive Impairment (MCI), a condition affecting memory and thinking skills. Researchers aim to determine if the patch can enhance attention, learning, and memory by acting on brain receptors involved in these functions. Participants will be randomly assigned to use either a nicotine patch or a placebo patch. Suitable candidates have noticeable memory concerns but not Alzheimer's and have not used tobacco products in the past year. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that people with mild cognitive impairment (MCI) can safely use nicotine patches for up to six months. One study found that participants using nicotine patches experienced more side effects than those using a placebo, with 82 side effects compared to 52. However, most side effects were mild. This indicates that while nicotine patches might cause minor issues, they are generally well-tolerated by people with MCI. Prospective trial participants may find it helpful to know that nicotine patches have been used before with some success and safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for MCI?

Unlike the standard treatments for mild cognitive impairment, which often focus on medications like cholinesterase inhibitors, the nicotine transdermal patch introduces a novel approach by using nicotine as the active ingredient. Researchers are excited about this treatment because nicotine is believed to enhance cognitive function by stimulating nicotinic receptors in the brain, which could potentially improve attention and memory. Additionally, the patch offers a unique delivery method, providing a steady, controlled release of nicotine, which minimizes the peaks and troughs associated with oral medications and could lead to better patient compliance and outcomes.

What evidence suggests that the nicotine transdermal patch could be an effective treatment for mild cognitive impairment?

Research has shown that nicotine patches might help with memory problems in people with mild cognitive impairment (MCI). In this trial, participants will join one of two groups: one will receive the Nicotine Transdermal Patch, and the other will receive a Placebo Patch. One study found that using a 15 mg nicotine patch for 6 months improved performance on memory tests. Another study suggested that nicotine could help with memory in people with early memory issues and early Alzheimer's. A review of several studies found that nicotine patches had positive effects on attention, but the impact on memory was not significant. These findings suggest that nicotine patches could be a promising option for improving certain mental functions in those with MCI. ^{1 2 5 6 7}

Who Is on the Research Team?

Paul Aisen, MD

Principal Investigator

USC Alzheimer's Therapeutic Research Institute (ATRI)

Paul Newhouse, MD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3466669/

Nicotine treatment of mild cognitive impairment: A 6-month ... This study provides Class I evidence that 6 months of transdermal nicotine (15 mg/day) improves cognitive test performance, but not clinical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00091468

Nicotine Treatment of Mild Cognitive Impairment (MCI) Preliminary studies have suggested that short-term administration of nicotine appears to improve memory in patients with mild memory loss and early Alzheimer's ...

3. michaeljfox.org michaeljfox.org/news/new-study-nicotine-patch-slows-memory-loss-mild-cognitive-impairment-similar-study-pd-horizon

New Study: Nicotine Patch Slows Memory Loss in Mild ... A nicotine patch may improve the memory loss common in mild cognitive impairment (MCI), a condition that is often a precursor to Alzheimer's disease.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ane.13436

Effects of transdermal nicotine delivery on cognitive ... The meta-analysis showed that transdermal nicotine had statistically significant positive effects on attention, and non-significant effects on memory, in ...

5. jwatch.org jwatch.org/jn201202070000008/2012/02/07/nicotine-mci

Nicotine for MCI? A small study of a nicotine patch in patients with mild cognitive impairment showed some benefit on a reaction-time test but no effect ...

6. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Nicotine-Cognitive-Vitality-For-Researchers.pdf

Nicotine ... mild cognitive impairment, a nicotine patch at 15 mg/day caused more adverse events than placebo (82 vs 52) although most of these events were mild and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6129985/

Transdermal Nicotine for the Treatment of Mood and Cognitive ... Nicotine may be a promising therapy for depressed mood and cognitive performance in LLD. A definitive placebo-controlled trial is necessary.