Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2002-06-30
2004-09-30
Brief Summary
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Cognitive dysfunction in people with AD is thought to arise from decreased chemical activity in specific parts of the brain. Decreases in alpha4beta2 nicotinic acetycholine receptors (nAChRs) have been found in the brains of people who died with AD; however, the status of this receptor system in living brains remains unclear. This study will use single photon emission computed tomography (SPECT) to study this receptor system in people with AD who have mild to moderate dementia and in healthy volunteers. In addition, this study will examine the relationship between cognitive dysfunction and nAChR deficits in the brains of individuals with AD.
Participants with AD will have four clinic visits; healthy volunteers will have three visits. At Visit 1, participants will undergo a medical history, physical examination, and laboratory tests. Healthy volunteers will have a Mini-Mental State Examination (MMSE) cognitive function test. Participants with AD will have a MMSE and measurement of the severity of their dementia.
During Visit 2, participants will undergo a magnetic resonance imaging (MRI) scan of the brain.
At Visit 3, participants will undergo SPECT imaging.
Only participants with AD will participate in Visit 4. During this visit, cognitive testing will be performed.
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Detailed Description
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Conditions
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Interventions
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[123] 5-I-A-85380
Eligibility Criteria
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Inclusion Criteria
The AD patients will be mild to moderately demented as assessed by the Mattis Dementia Rating Scale and Mini-Mental State Examination.
In particular, the AD patients will be nonsmokers because of known effects of smoking on nAChRs.
Patients will be characterized by their APOE genotype as nAChR changes might be different with differing doses of this allele.
We will not exclude AD patients from participating while they are on AChe inhibitors.
Exclusion Criteria
We will exclude patients on antidepressants and/or psychotropic drugs.
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Locations
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National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States
Countries
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References
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Coyle JT, Puttfarcken P. Oxidative stress, glutamate, and neurodegenerative disorders. Science. 1993 Oct 29;262(5134):689-95. doi: 10.1126/science.7901908.
Corder EH, Saunders AM, Strittmatter WJ, Schmechel DE, Gaskell PC, Small GW, Roses AD, Haines JL, Pericak-Vance MA. Gene dose of apolipoprotein E type 4 allele and the risk of Alzheimer's disease in late onset families. Science. 1993 Aug 13;261(5123):921-3. doi: 10.1126/science.8346443.
Saunders AM, Strittmatter WJ, Schmechel D, George-Hyslop PH, Pericak-Vance MA, Joo SH, Rosi BL, Gusella JF, Crapper-MacLachlan DR, Alberts MJ, et al. Association of apolipoprotein E allele epsilon 4 with late-onset familial and sporadic Alzheimer's disease. Neurology. 1993 Aug;43(8):1467-72. doi: 10.1212/wnl.43.8.1467.
Other Identifiers
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02-M-0058
Identifier Type: -
Identifier Source: secondary_id
020058
Identifier Type: -
Identifier Source: org_study_id
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