Nicotine Treatment of Mild Cognitive Impairment (MCI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Institute on Aging (NIA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00091468
First received: September 9, 2004
Last updated: January 7, 2008
Last verified: January 2008
  Purpose

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
Age-Related Memory Disorders
Drug: Transdermal nicotine patch
Drug: Placebo transdermal patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind Treatment of Mild Cognitive Impairment (MCI) With Transdermal Nicotine or Transdermal Placebo

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Safety of transdermal nicotine patch [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in cognitive performance [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Change in global functioning [ Time Frame: 13 months ] [ Designated as safety issue: No ]

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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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):

    1. less than or equal to 8 for 16 or more years of education,
    2. less than or equal to 4 for 8 - 15 years of education,
    3. 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.

Exclusion Criteria:

  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091468

Locations
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
Sponsors and Collaborators
Investigators
Principal Investigator: Paul Newhouse, MD University of Vermont
  More Information

Additional Information:
Publications:
Responsible Party: Paul Newhouse, M.D., University of Vermont
ClinicalTrials.gov Identifier: NCT00091468     History of Changes
Other Study ID Numbers: IA0060, R01 AG022462-02
Study First Received: September 9, 2004
Last Updated: January 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Aging (NIA):
Age-Related Memory Loss
Nicotine
Mild Cognitive Impairment (MCI)

Additional relevant MeSH terms:
Memory Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014