NCT00001977

Brief Summary

This study will examine whether enhancing the chemical acetylcholine in the brain can improve memory and attention. It will identify changes in brain function that occur during these cognitive tasks. Animal and human studies have shown that a decrease in acetylcholine may be responsible for some of the cognition deficits in Alzheimer's disease. Conversely, patients taking medications that slow the breakdown of this neurotransmitter have experienced improvements in memory. Normal volunteers and patients with Alzheimer's disease may be eligible for this study of functional brain imaging using positron emission tomography (PET) and magnetic resonance imaging (MRI). These techniques can measure brain activity and identify brain regions involved in memory and attention. Candidates for this study will be screened with a medical and psychiatric history and a physical examination including blood tests, urinalysis, chest X-ray, and electrocardiogram (ECG). Those enrolled will perform memory and attention tasks during PET and MRI studies. The cognition tasks will be repeated twice-once during infusion of saline (a fluid with no drug effect) through a catheter inserted into a blood vessel and again during infusion of physostigmine, a drug that delays the breakdown of acetylcholine. The PET procedure will be completed in one day; the MRI procedure will be done on two different days. During imaging, attention and memory tasks will be presented in short blocks of about 4-minutes duration. They will be repeated in sequence up to 10 times with a few minutes separation. Subjects will be shown pictures of faces or other visual stimuli and asked to decide whether the pictures are the same or different. Information gained from this study may increase knowledge about how acetylcholine affects the brain's response to memory and attention tasks and perhaps lead to better treatments for the cognitive deficits in Alzheimer's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2000

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2000

First QC Date

January 20, 2000

Last Update Submit

March 3, 2008

Conditions

Keywords

Alzheimer's DiseaseAttentionBrainFunctional Magnetic Resonance ImagingPhysostigminePositron Emission TomographyWorking Memory

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Three groups of subjects will be enrolled: Subjects with Alzheimer's Disease (AD) 45-100 years of age; Healthy controls 20-50 years of age; Healthy controls 50-90 years of age. No evidence of, or history of, any medical, neurological or psychiatric condition (other than dementia in the AD patient group) which may affect brain function and metabolism and/or represent a contraindication to the study; including learning disability, psychiatric condition, head trauma with loss of consciousness, seizures or other neurological conditions, alcoholism or substance abuse, hypertension, cardiovascular disease, diabetes and other endocrine diseases, malignancy. No subjects with vision and/or hearing problems severe enough to interfere with testing. No females with a positive pregnancy test. No subjects with contraindications to magnetic resonance imaging (MRI), including pacemakers, cochlear implants, surgical clips or metal fragments in their eyes or body parts. Only subjects with good health and without evidence of significant chronic disease will be accepted into the healthy control groups. Only patients without evidence of significant chronic disease who meet standard clinical criteria for the diagnosis of dementia of Alzheimer's disease type will be accepted into the study in the AD group.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Baddeley AD, Bressi S, Della Sala S, Logie R, Spinnler H. The decline of working memory in Alzheimer's disease. A longitudinal study. Brain. 1991 Dec;114 ( Pt 6):2521-42. doi: 10.1093/brain/114.6.2521.

    PMID: 1782529BACKGROUND
  • Bajalan AA, Wright CE, van der Vliet VJ. Changes in the human visual evoked potential caused by the anticholinergic agent hyoscine hydrobromide: comparison with results in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 1986 Feb;49(2):175-82. doi: 10.1136/jnnp.49.2.175.

    PMID: 3950635BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 20, 2000

First Posted

December 10, 2002

Study Start

January 1, 2000

Study Completion

April 1, 2001

Last Updated

March 4, 2008

Record last verified: 2000-01

Locations