Memory Improvement Through Nicotine Dosing (MIND) Study
Lay Description
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.
Category
- Nervous System
- Dementia / Alzheimers
- Aging and Geriatric
- IRB Number
- 20180378HU
- NCT Number
- NCT02720445
Eligibility
- Eligible Ages
- Between 55 Years and 90 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
1. Participant must have a subjective memory concern as reported by participant, study partner, or clinician 2. Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised: - less than or equal to 11 for 16 or more years of education - less than or equal to 9 for 8 - 15 years of education - less than or equal to 6 for 0 - 7 years of education 3. Mini-Mental State Exam score between 24 and 30, inclusive 4. Clinical Dementia Rating (CDR) Global = 0.5. Memory Box score must be at least 0.5 5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease dementia cannot be made by the site physician at the time of the screening visit 6. Age 55-90 (inclusive) 7. Stable permitted medications for 4 weeks or longer as specified in Section 6, including: • Memantine and cholinesterase inhibitors are allowable if stable for 12 weeks prior to screen 8. Geriatric Depression Scale score of less than or equal to 14 9. Study Partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to most visits to answer questions about the participant 10. Adequate visual and auditory acuity to allow neuropsychological testing 11. Good general health with no additional diseases/disorders expected to interfere with the study 12. Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile) 13. Completed six grades of education or has a good work history 14. Must speak English fluently
Exclusion Criteria
Study Design
Arm Groups
Study Contact
Floyd Jones
210-450-3158
jonesfa@uthscsa.edu
Principal Investigator
Sudha Seshadri