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Long-Term Nicotine Treatment of Mild Cognitive Impairment

The purpose of this study is to determine whether nicotine can improve symptoms of memory loss in people experiencing mild memory problems (referred to in this study as “mild cognitive impairment” or MCI). 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 attention. In people with MCI (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 nicotine 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 FDA approved for use in people who are trying to quit smoking.

Subjects will be asked to come to the Penn State Health Milton S. Hershey Medical Center for a screening visit, which will determine eligibility. This visit includes blood work, a urine sample, an ECG, a physical and neurological exam, memory/cognitive tasks, and vital signs. Certain portions can be done remotely via phone. If eligible, subjects will be randomized to wear a nicotine patch or placebo and will complete 11 more visits about once every three months over two years. Some visits are longer than others and are a combination of in-person activities and remote participation via phone. Subjects will be asked to report medication changes and adverse events at every visit.

$600

Paul Eslinger
psniclinresearch@pennstatehealth.psu.edu
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02720445
STUDY00008978
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Inclusion Criteria:
Patient must have a subjective memory concern as reported by patient, study partner, or clinician
Age 55-90 (inclusive)
Study Partner is available who has frequent contact with the patient (e.g. an average of 10 hours per week or more), and can accompany the patient to most visits to answer questions about the patient
Must speak English or Spanish fluently
Good general health with no additional diseases/disorders expected to interfere with the study

Exclusion Criteria:
Any use of tobacco or nicotine products within the past year
Any significant neurologic disease such as Alzheimer’s disease dementia, Parkinson’s disease, multi-infarct dementia, brain tumor, seizure disorder, etc.
History of alcohol or substance abuse or dependence within the past 2 years
Neurology, Mental & Behavioral Health
Experimental drug compared to a placebo/”sugar pill”
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Location Contacts
Hershey, PA ,