NCT00039702

Brief Summary

The purpose of this study is to use brain imaging technology to examine the role of certain brain chemicals in individuals with Alzheimer's 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2002

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2002

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

September 1, 2004

First QC Date

June 6, 2002

Last Update Submit

March 3, 2008

Conditions

Keywords

Nicotinic Acetylcholine ReceptorsAlzheimer's DiseaseSPECTADHealthy VolunteerHVNormal Control

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All AD patients will meet NINCDS-ADRDA criteria for probable AD with age of onset between 50 and 65 years of age.
  • 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.

You may not qualify if:

  • We will exclude patients who are on galanthamine (Reminyl).
  • We will exclude patients on antidepressants and/or psychotropic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Coyle JT, Puttfarcken P. Oxidative stress, glutamate, and neurodegenerative disorders. Science. 1993 Oct 29;262(5134):689-95. doi: 10.1126/science.7901908.

    PMID: 7901908BACKGROUND
  • 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.

    PMID: 8346443BACKGROUND
  • 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.

    PMID: 8350998BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

5-iodo-3-(2-azetidinylmethoxy)pyridine

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

June 6, 2002

First Posted

June 7, 2002

Study Start

June 1, 2002

Study Completion

September 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-09

Locations