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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00091468 |
The purpose of this 12-month study is to determine whether nicotine, administered in the form of nicotine patches, can improve symptoms of memory loss in some people experiencing mild memory problems (referred to in this study as "mild cognitive impairment" or MCI).
Condition | Intervention | Phase |
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Age-Related Memory Disorders |
Drug: Transdermal nicotine patch Drug: Placebo transdermal patch |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Double-Blind Treatment of Mild Cognitive Impairment (MCI) With Transdermal Nicotine or Transdermal Placebo |
Estimated Enrollment: | 75 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo Group: Placebo Comparator
Placebo for first six months of study; moved to open-label active nicotine for second six months
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Drug: Placebo transdermal patch
placebo patch, 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks
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Active Nicotine Group: Experimental
Blinded active nicotine for first six months of study; open-label active nicotine for second six months
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Drug: Transdermal nicotine patch
double-blind phase: 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks open label phase: 5mg for 1 week, 10mg. for 2 weeks, 15mg. for 23 weeks taper down: 10mg. for 2 weeks, 5mg. for 1 week
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The purpose of this study is to determine whether nicotine can improve symptoms of memory loss in some people experiencing mild memory problems (referred to in this study as "mild cognitive impairment" or MCI). The study will last approximately 12 months and will be conducted at 3 clinical sites in the United States.
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 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.
Nicotine imitates many of the actions of acetylcholine. By administering nicotine over a longer period of time to patients with MCI, this study could lead to a better understanding of whether nicotine can act to improve memory loss symptoms over the longer term and whether it can help delay the progression of memory loss symptoms. The amount of nicotine in each patch used in this study is the same level found in patches that are used in people who are trying to quit smoking. This study will include up to twelve visits.
Ages Eligible for Study: | 55 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Specific Inclusion Criteria:
Abnormal memory function documented by scoring below the education adjusted cutoff on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised (the maximum score is 25):
Exclusion Criteria:
Exceptions to these specific Inclusion and Exclusion Criteria (e.g., WMS-R cutoffs) may be made on a case by case basis by the Principal Investigator.
United States, District of Columbia | |
Georgetown University Medical Center, Department of Neurology | |
Washington, District of Columbia, United States, 20057 | |
United States, North Carolina | |
Duke University, Duke Health Center at Morreene Road | |
Durham, North Carolina, United States, 27705 | |
United States, Vermont | |
University of Vermont College of Medicine | |
Burlington, Vermont, United States, 05401 |
Principal Investigator: | Paul Newhouse, MD | University of Vermont |
Responsible Party: | University of Vermont ( Paul Newhouse, M.D. ) |
Study ID Numbers: | IA0060, R01 AG022462-02 |
Study First Received: | September 9, 2004 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00091468 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Age-Related Memory Loss Nicotine Mild Cognitive Impairment (MCI) |
Nicotine polacrilex Neurotransmitter Agents Nicotinic Agonists Central Nervous System Stimulants Cholinergic Agents Memory Disorders Cognition Disorders Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Nicotine Neurologic Manifestations Peripheral Nervous System Agents Dementia Neurobehavioral Manifestations Amnesia Delirium |
Nicotine polacrilex Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Nicotinic Agonists Physiological Effects of Drugs Nervous System Diseases Central Nervous System Stimulants Cholinergic Agents Memory Disorders Pharmacologic Actions Cognition Disorders |
Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nicotine Autonomic Agents Therapeutic Uses Ganglionic Stimulants Neurologic Manifestations Peripheral Nervous System Agents Central Nervous System Agents Neurobehavioral Manifestations |