Nicotine Treatment of Mild Cognitive Impairment (MCI)
Double-Blind Treatment of Mild Cognitive Impairment (MCI) With Transdermal Nicotine or Transdermal Placebo
2 other identifiers
interventional
75
1 country
3
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2003
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2004
CompletedFirst Posted
Study publicly available on registry
October 14, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJanuary 15, 2008
January 1, 2008
4.8 years
September 9, 2004
January 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of transdermal nicotine patch
13 months
Secondary Outcomes (2)
Change in cognitive performance
13 months
Change in global functioning
13 months
Study Arms (2)
Placebo Group
PLACEBO COMPARATORPlacebo for first six months of study; moved to open-label active nicotine for second six months
Active Nicotine Group
EXPERIMENTALBlinded active nicotine for first six months of study; open-label active nicotine for second six months
Interventions
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
placebo patch, 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks
Eligibility Criteria
You may qualify if:
- 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.
- +3 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Georgetown University Medical Center, Department of Neurology
Washington D.C., District of Columbia, 20057, United States
Duke University, Duke Health Center at Morreene Road
Durham, North Carolina, 27705, United States
University of Vermont College of Medicine
Burlington, Vermont, 05401, United States
Related Publications (3)
Newhouse PA, Potter A, Singh A. Effects of nicotinic stimulation on cognitive performance. Curr Opin Pharmacol. 2004 Feb;4(1):36-46. doi: 10.1016/j.coph.2003.11.001.
PMID: 15018837BACKGROUNDNewhouse P, Singh A, Potter A. Nicotine and nicotinic receptor involvement in neuropsychiatric disorders. Curr Top Med Chem. 2004;4(3):267-82. doi: 10.2174/1568026043451401.
PMID: 14754447BACKGROUNDNewhouse PA, Potter A, Kelton M, Corwin J. Nicotinic treatment of Alzheimer's disease. Biol Psychiatry. 2001 Feb 1;49(3):268-78. doi: 10.1016/s0006-3223(00)01069-6. No abstract available.
PMID: 11230878BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Newhouse, MD
University of Vermont
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 9, 2004
First Posted
October 14, 2004
Study Start
September 1, 2003
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
January 15, 2008
Record last verified: 2008-01