Clinical Trial: Neurology

MIND- Memory Improvement through Nicotine Dosing

Description

The purpose of this study is to determine whether nicotine can improve symptoms of memory loss in people experiencing mild memory problems (mild cognitive impairment).

Recent studies have suggested that one of the causes of memory disorders may be a reduction in a particular chemical substance in the brain. This chemical substance, acetylcholine, is thought to act on certain brain cells in a specific way that helps us to remember and use memories as well as affect our mood.  

In people with mild cognitive impairment (and Alzheimer’s disease), the level of acetylcholine may be changed, and this may impair brain functioning. Preliminary studies have suggested that short-term administration of nicotine appears to improve memory in patients with mild memory loss and early Alzheimer’s disease (AD). It has been known for many years that nicotine imitates many of the actions of acetylcholine.  

By administering a nicotine patch over a longer period of time to participants with MCI, we hope to better understand whether nicotine may act to improve memory loss symptoms over the longer term and whether it may help to delay the progression of memory loss symptoms.  

The amount of nicotine in each patch used in this study is the same as patches that are used in people who are trying to quit smoking and has not been associated with nicotine dependence.

To participate, please contact:

Andrew Orzel, RN, BSN
Network Office of Research & Innovation
610-402-9543

Eligibility

Inclusion Criteria

Participants must meet the following 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

3. Mini-Mental State Exam score between 24 and 30, inclusive

4. Clinical Dementia Rating (CDR) Global on a standardized scoring system    

5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer’s disease dementia cannot be made by the site clinician 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 6.10, including: Memantine is allowable if stable for 12 weeks prior to screen

8. Geriatric Depression Scale score of less than or equal to 9

9. Study Partner is available who has frequent contact with the subject (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

Doctor(s) Running This Study