Overview

This trial is active, not recruiting.

Condition alzheimer disease
Sponsor Centre Hospitalier Universitaire de Nīmes
Start date February 2011
End date March 2016
Trial size 143 participants
Trial identifier NCT01231295, 2009-013476-53, PHRC-N/2009/POK-01

Summary

The primary objective of this study is to characterize cerebral metabolism modifications using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal Alzheimer's Disease drawn from a high risk population. We also compare PET and SPECT imaging within this framework, and search for optimal diagnostic thresholds.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Group with clinically validated memory problems
Group without memory problems

Primary Outcomes

Measure
The difference between AUCs for PET and SPECT imaging
time frame: 1 month

Eligibility Criteria

Male or female participants at least 70 years old.

Inclusion Criteria for the group with memory problems: - patient consulting for memory problems - caucasian - memory complaint is validated by a clinical evaluation - cognitive performance is sufficiently well preserved so that a diagnostic of dementia cannot be made (according to the DSM-IV-R and NINCDS-ADRDA criteria) at the time of inclusion - the patient speaks French - presence of an informant - accepts to sign consent Inclusion Criteria for the group without memory problems (reference population): - at least four years of formal education - patient consulting for memory problems - memory problem reported by the patient is not validated by the consultation, nor by the battery of tests specified during screening - presence of an informant - Clinical Dementia Rating (CDR) = 0 - accepts to sign consent Exclusion Criteria: - Instrumental Activities of Daily Living (IADL): at least two items > 1 - Anticholinesterasic treatments and/or memantin before study inclusion - major depressive syndrome, according to the Global Depressive Scale - Known neurodegenerative disease or general disease or major physical problems that could interfere with cognitive functioning and testing - Pathology that might lead to death in the short term (evolving cancer, non stable cardiopathy, hepatic, renal or respiratory insufficiency) - contra-indications for MRI, PET or SPECT scans - not affiliated with a social security regimen

Additional Information

Official title Evaluating the Performance of Isotopic Brain Imaging of Glucose Metabolism Via PET (18F-FDG) and Perfusion SPECT (99mTc-ECD) for the Diagnosis of Prodromal Stage Alzheimer's Disease
Principal investigator Pierre Olivier Kotzki, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes.