NCT00001917

Brief Summary

The purpose of this study is to use brain imaging technology to study the effects of aging and Alzheimer's Disease (AD) on a specific type of brain receptor. The brain is made up of cells called neurons. The neurons communicate with one another and secrete chemicals called neurotransmitters. The neurotransmitters bind to specific sites on other neurons called receptors. Acetylcholine (ACh) is a neurotransmitter that binds to ACh receptors. In both aging and AD, the number of neurons that secrete ACh decreases and the function of some ACh receptors changes. This study will use positron emission tomography (PET) scans of the brain to study the effects of age and AD on muscarinic type 2 \[M2\], a type of ACh receptor. Participants in this study will be injected with a radioactive tracer (ligand \[F-18\] FP-TZTP) which binds to \[M2\] receptors. Participants will then undergo a PET scan in order for the density and function of \[M2\] receptors to be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 1999

Longer than P75 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

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2005

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Alzheimer's DiseaseHealthy

Keywords

Positron Emission TomographyPhysostigmineVisual StimulationCholinergic Stimulation[F-18] FP-TZIPAgingAlzheimer's DiseaseVisual Activation

Interventions

O15DRUG
[F-18] FP-TZTPDRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy males and females between 20-100 years old and volunteers with AD.
  • AD volunteers must meet the NINCDS-ADRDA criteria for possible, probable, or definite AD.
  • All subjects will be required to be off all prescription medications which could effect the PET scan, such as medications with anticholinergic effects, for two weeks to one month prior to the PET scan, and off psychotropic medication for one month.
  • Subjects will be cautioned not to consume alcohol, marijuana, or psychotropic drugs while on the study, nor to smoke, use caffeinated beverages, or take over-the-counter medications such as cold medications (ie: Benadryl, Sudafed) for at least 12 hours prior to the PET scan.

You may not qualify if:

  • Patients withe significant cardiovascular disease, history of alcoholism, significant head trauma, uncontrolled hypertension, diabetes, bleeding disorders or other medical conditions which would make it medically unsafe to perform any part of the PET scan or would confound data analysis.
  • Subjects with evidence of significant chronic disease to be accepted into the healthy control group.
  • Subjects must not be pregnant.

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)

  • Christie JE, Shering A, Ferguson J, Glen AI. Physostigmine and arecoline: effects of intravenous infusions in Alzheimer presenile dementia. Br J Psychiatry. 1981 Jan;138:46-50. doi: 10.1192/bjp.138.1.46.

    PMID: 7023592BACKGROUND

  • Davis KL, Hollister LE, Overall J, Johnson A, Train K. Physostigmine: effects on cognition and affect in normal subjects. Psychopharmacology (Berl). 1976 Dec 21;51(1):23-7. doi: 10.1007/BF00426316.

    PMID: 827772BACKGROUND

  • Davis KL, Mohs RC. Enhancement of memory processes in Alzheimer's disease with multiple-dose intravenous physostigmine. Am J Psychiatry. 1982 Nov;139(11):1421-4. doi: 10.1176/ajp.139.11.1421.

    PMID: 6753611BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

FP-TZTP

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

November 3, 1999

First Posted

November 4, 1999

Study Start

April 1, 1999

Study Completion

April 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-04

Locations

US(1)