Nicotine Treatment of Mild Cognitive Impairment (MCI)
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|ClinicalTrials.gov Identifier: NCT00091468|
Recruitment Status : Unknown
Verified January 2008 by National Institute on Aging (NIA).
Recruitment status was: Active, not recruiting
First Posted : October 14, 2004
Last Update Posted : January 15, 2008
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|Condition or disease||Intervention/treatment||Phase|
|Age-Related Memory Disorders||Drug: Transdermal nicotine patch Drug: Placebo transdermal patch||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-Blind Treatment of Mild Cognitive Impairment (MCI) With Transdermal Nicotine or Transdermal Placebo|
|Study Start Date :||September 2003|
|Estimated Primary Completion Date :||July 2008|
|Estimated Study Completion Date :||July 2008|
Placebo Comparator: Placebo Group
Placebo for first six months of study; moved to open-label active nicotine for second six months
Drug: Placebo transdermal patch
placebo patch, 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks
Experimental: Active Nicotine Group
Blinded active nicotine for first six months of study; open-label active nicotine for second six months
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
Other Name: Nicotrol
- Safety of transdermal nicotine patch [ Time Frame: 13 months ]
- Change in cognitive performance [ Time Frame: 13 months ]
- Change in global functioning [ Time Frame: 13 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||55 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Specific Inclusion Criteria:
- Age 55+.
- Memory complaints and memory difficulties which are verified by an informant.
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):
- less than or equal to 8 for 16 or more years of education,
- less than or equal to 4 for 8 - 15 years of education,
- less than or equal to 2 for 0 - 7 years of education.
- Mini-Mental Status Exam score between 24 and 30 (inclusive).
- Clinical Dementia Rating of 0.5 with a memory box score of 0.5 or 1.0.
- General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit.
- No significant cerebrovascular disease: Modified Hachinski score of less than or equal to 4.
- Stable medications for at least 1 month prior to screening.
- Hamilton Depression rating scale score of less than or equal to 12 on the 17-item scale.
- Informant is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more).
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Good general health with no additional diseases expected to interfere with the study.
- Any conditions that subject may have must be stable for 3 months prior to screening.
- Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
- Participants will be taking no drugs with pro- or anti-cholinergic properties.
- Any significant neurologic disease such as Alzheimer's disease, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- Major depression or another major psychiatric disorder as described in DSM-IV within the past 2 years.
- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
- Any significant, unstable medical condition.
- Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.
- Any tobacco use within the past year.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091468
|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:||Paul Newhouse, M.D., University of Vermont|
|Other Study ID Numbers:||
R01AG022462-02 ( U.S. NIH Grant/Contract )
|First Posted:||October 14, 2004 Key Record Dates|
|Last Update Posted:||January 15, 2008|
|Last Verified:||January 2008|
Age-Related Memory Loss
Mild Cognitive Impairment (MCI)
Nervous System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action