Memory Improvement Through Nicotine Dosing (MIND) Study (MIND)
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|ClinicalTrials.gov Identifier: NCT02720445|
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : March 17, 2021
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 300 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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Drug: Nicotine Transdermal Patch Drug: Placebo Patch||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Long-Term Nicotine Treatment of Mild Cognitive Impairment|
|Actual Study Start Date :||January 13, 2017|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2023|
Experimental: Nicotine Transdermal Patch
150 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
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.
Placebo Comparator: Placebo Patch
150 participants will wear matching placebo patches during waking hours.
Drug: Placebo Patch
Matching placebo patches worn during waking hours.
- Change from Baseline of the Conners Continuous Performance Task (CPT) to Month 25 [ Time Frame: 2 years ]
- Change from Baseline in Mild Cognitive Impairment - Clinical Global Impression of Change (MCI-CGIC) to Month 25 [ Time Frame: 2 years ]The MCI-CGIC is the MCI version of the clinician's global impression of change. In this trial it will measure change in the participant's condition between the baseline visit and subsequent visits.
- Change from Baseline in Cogstate Brief Battery (CBB) to Month 25 [ Time Frame: 2 years ]This battery will be used for the purpose of assessing the cognitive status of the participants and will assist in documenting multiple domains of cognitive impairment.
- Change in Baseline in New York University (NYU) Paragraph Recall to Month 25 [ Time Frame: 2 years ]This test measures immediate and delayed verbal recall of a brief story.
- Change from Baseline in Clinical Dementia Rating Scale (CDR) - Sum of Boxes (SOB) to Month 25 [ Time Frame: 2 years ]The is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe.
- Change in Baseline in Geriatric Depression Scale (GDS) to Month 25 [ Time Frame: 2 years ]This is a 30-item self-report assessment used to identify depression in the elderly.
- Change in Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) to Month 25 [ Time Frame: 2 years ]This scale is an inventory developed to assess functional performance in participantss with Alzheimer's disease.
- Change from Baseline in Older Adult Self Report (OASR) / Older Adult Behavior Checklist (OABCL) to Month 25 [ Time Frame: 2 years ]The OASR/OABCL is a general index of psychopathologic symptoms and signs that is specifically relevant to elderly individuals and is developmentally appropriate, covers a wide range of psychopathologic signs and symptoms, and functional measures. It allows multi-informant perspective (both patient and informant). The items are focused on common elderly emotional, functional, or medical problems. The OASR is completed by the participant and the companion OABCL is completed by the informant.
- Change from Baseline in Cerebral Spinal Fluid (CSF) Biomarkers to Month 25 [ Time Frame: 2 years ]CSF will be performed in approximately 50 participants each
- Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Month 25 [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720445
|Contact: ATRI Recruitmentfirstname.lastname@example.org|
|Study Director:||Paul Aisen, MD||USC Alzheimer's Therapeutic Research Institute (ATRI)|
|Study Director:||Paul Newhouse, MD||Vanderbilt University|