Viewing Study NCT00039702



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Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00039702
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 2002-06-06

Brief Title: Brain Imaging in Alzheimers Disease
Sponsor: National Institute of Mental Health NIMH
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: SPECT Imaging of Alpha4beta2 Nicotinic Acetylcholine Receptors Using 123I5-I-A-85380 in Alzheimers Disease
Status: COMPLETED
Status Verified Date: 2004-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to use brain imaging technology to examine the role of certain brain chemicals in individuals with Alzheimers disease AD and in healthy volunteers

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
Detailed Description: Cognitive dysfunction in Alzheimers disease AD patients are thought to arise in part from underlying losses of cholinergic input to cerebral cortex and hippocampus Consistent marked decreases of alpha4beta2 nicotinic acetylcholine receptors nAChRs are found in postmortem AD brains However knowledge of the in vivo status of this receptor system is limited due to the lack of suitable tracers for PETSPECT imaging We plan to use a new SPECT tracer 123I5-I-A-85380 which appears suitable for imaging the alpha4beta2 subtype of nAChRs in order to delineate abnormalities of this receptor system in a subgroup of 20 mild to moderately demented AD patients against 20 age matched healthy controls the subgroup being characterized by carrying the AD susceptibility Apolipoprotein E epsilon4 allele In addition we plan to examine the relationship between cognitive dysfunction and alpha4beta2 nAChr deficits in the cerebral cortex and hippocampus of these AD patients This study represents our initial effort toward our long-term goal of understanding the role this important receptor system plays in the pathophysiological mechanisms and drug manipulation of AD

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
02-M-0058 None None None