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PET Study of the Nicotinic Receptors in Human

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00543322
First Posted: October 12, 2007
Last Update Posted: October 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Commissariat A L'energie Atomique
  Purpose
The purpose of this study is to quantify the brain distribution of the nicotinic receptors in human volunteers and their alterations in patients suffering from neurological diseases such as Parkinson and Alzheimer diseases and familial epilepsy. This will be done using Postron Emission Tomography (PET) and a new radiotracer of the nicotinic receptors.

Condition Phase
Healthy Parkinson Disease Alzheimer Disease Epilepsy Phase 1 Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: PET Study of the Nicotinic Receptors in Human : Brain Distribution and Quantification

Resource links provided by NLM:


Further study details as provided by Commissariat A L'energie Atomique:

Study Start Date: July 2001
Study Completion Date: July 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

General Inclusion criteria:

  • Subjects under 60 years are only male.
  • Subjects from 60 to 85 may be male or female
  • Subjects that have a Health insurance
  • Subjects will be asked to refrain from caffein for at least 12 hours

Specific inclusion criteria for part 2:

  • Subjects with

Specific inclusion criteria for part 3:

  • Subjects with Alzheimer diseased based on the DSM IV and NINCDS-ADRDA criteria. With a MMS between 15 and 26 (included).
  • Subjects capable of giving an informed consent and accompagined by a person of confidence

Specific inclusion criteria for part 4:

  • Subjects with ADNFLE with or without demonstrated mutation on the nicotinic receptors

Exclusion Criteria:

General exclusion criteria:

  • Subjects with abnormal MRI findings at visual inspection
  • Subjects with a history of significant medical disordres, or requiering chronic treatment that interfere with the cholinergic system
  • Subjects with abnormal plasma biological analysis
  • Subjects with significant past and present history of hypertension, cardiovascular disease and diabetes mellitus
  • Subjects who have pacemakers, aneurysm clips (metal clips) metallic prostheses (including heart valves and cochlear implants) or shrapnel fragments.
  • Subjects incapable of giving an informed consent

Specific exclusion criteria for part 2:

  • Subjects with a smoking history in the last five years

Specific exclusion criteria for part 3:

  • Subjects with a smoking history in the last five years

Specific exclusion criteria for part 4:

  • Subjects with a smoking history in the last five years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543322


Locations
France
CEA, Service Hospitalier Frederic Joliot
Orsay, France, 91400
Sponsors and Collaborators
Commissariat A L'energie Atomique
Investigators
Principal Investigator: MICHEL BOTTLAENDER, MD PhD CEA
  More Information

ClinicalTrials.gov Identifier: NCT00543322     History of Changes
Other Study ID Numbers: SHFJ-100008
First Submitted: October 11, 2007
First Posted: October 12, 2007
Last Update Posted: October 12, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Parkinson Disease
Alzheimer Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders