Memory Improvement Through Nicotine Dosing (MIND) Study (MIND)
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.
|Mild Cognitive Impairment||Drug: Nicotine Transdermal Patch Drug: Placebo Patch||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Long-Term Nicotine Treatment of Mild Cognitive Impairment|
- 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 subject'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 subjects 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 subjects 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 subject 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 ]
|Actual Study Start Date:||January 13, 2017|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02720445
|Contact: ATRI Recruitmentfirstname.lastname@example.org|
|United States, California|
|USC Rancho Los Amigos||Not yet recruiting|
|Downey, California, United States, 90242|
|Syrentis Clinical Research||Recruiting|
|Santa Ana, California, United States, 92705|
|Contact: Maria Medina 714-542-3008 ext 308 MMedinaCRC@gmail.com|
|Principal Investigator: John Duffy, MD|
|United States, District of Columbia|
|Washington, D.C., District of Columbia, United States, 200072145|
|Contact: Margaret Bassett 202-687-2352 email@example.com|
|Principal Investigator: Raymond Scott Turner, MD, PhD|
|United States, Florida|
|Brain Matters Research||Recruiting|
|Delray Beach, Florida, United States, 33445|
|Contact: Jetliza Lesmes 561-374-8461 ext 110 firstname.lastname@example.org|
|Principal Investigator: Mark Brody, MD, CPI|
|Miami Jewish Health Systems||Not yet recruiting|
|Miami, Florida, United States, 33137|
|United States, Illinois|
|Chicago, Illinois, United States, 606113010|
|Contact: Jordan Robson 312-503-5212 email@example.com|
|Principal Investigator: Ian Grant, MD|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Karen Ekstam-Smith 319-353-5158 firstname.lastname@example.org|
|Principal Investigator: Delwyn Miller, MD|
|United States, Maine|
|Acadia Hospital||Not yet recruiting|
|Bangor, Maine, United States, 04402|
|United States, New Mexico|
|University of New Mexico||Recruiting|
|Albuquerque, New Mexico, United States, 87106|
|Contact: Justine Saavedra 505-272-5631 email@example.com|
|Principal Investigator: Gary Rosenberg, MD|
|United States, New York|
|New York University Medical Center||Not yet recruiting|
|New York, New York, United States, 100166055|
|Mount Sinai School of Medicine||Recruiting|
|New York, New York, United States, 100296552|
|Contact: Allison Ardolino 212-241-0438 firstname.lastname@example.org|
|Principal Investigator: Clara Li, PhD|
|United States, North Carolina|
|Wake Forest University Health Sciences||Not yet recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Oklahoma|
|Tulsa Clinical Research||Recruiting|
|Tulsa, Oklahoma, United States, 74104|
|Contact: John Parsons email@example.com|
|Principal Investigator: Ralph Richter, MD|
|United States, South Carolina|
|Roper St. Francis Hospital||Not yet recruiting|
|Charleston, South Carolina, United States, 294011113|
|United States, Tennessee|
|Meharry Medical College||Not yet recruiting|
|Nashville, Tennessee, United States, 37208|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37212|
|Contact: Sally Ross 615-875-0955 firstname.lastname@example.org|
|Principal Investigator: Meghan Riddle, MD|
|United States, Texas|
|Houston Methodist Neurological Institute||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Study Director:||Paul Aisen, MD||USC Alzheimer's Therapeutic Research Institute (ATRI)|
|Study Director:||Paul Newhouse, MD||Vanderbilt University|