Isotopic Imaging for Prodromal Alzheimer's Disease

Alzheimer Disease Clinical Trial

— ISALP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231295
• Other study ID #: PHRC-N/2009/POK-01
• Secondary ID: 2009-013476-53
• Status: Completed
• Phase: N/A
• First received: October 29, 2010
• Last updated: January 31, 2017
• Start date: February 2011
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
France	CHU d'Amiens - Hôpital Sud	Amiens Cedex 1
France	CHU d'Angers - Hôtel-Dieu	Angers
France	CHU de Besançon - Hôpital Jean Minjoz	Besançon
France	CHU de Bordeaux - Groupe Hospitalier Pellegrin	Bordeaux
France	APHP - Hôpital Albert Chenevier	Creteil Cedex
France	APHP - Hôpital Charles Foix	Ivry Sur Seine Cedex
France	CHRU de Lille - Hôpital Claude Huriez	Lille
France	CHRU de Lille - Hôpital Roger Salengro	Lille
France	APHP - Hôpital Emile Roux	Limeil Brevannes Cedex
France	APHM - Hôpital La Timone Adultes	Marseille cedex 5
France	CHU de Montpellier - Hôpital Gui de Chauliac	Montpellier Cedex 5
France	CHU de Nancy - Hôpital Central	Nancy
France	CHU de Nice - Hôpitaux L'Archet 1 et 2	Nice
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	APHP - Hôpital Broca	Paris
France	APHP - Hôpital Lariboisière	Paris
France	Groupe Hospitalier Paris Saint-Joseph	Paris
France	APHP - Groupe Hospitalier Pitié-Salpetrière	Paris cedex 13
France	CHU de Poitiers	Poitiers
France	CHU de Reims - Hôpital Maison Blanche	Reims
France	CHU de Rouen - Hôpital Charles Nicolle	Rouen
France	CHRU de Strasbourg - Hôpital de Hautepierre	Strasbourg
France	CHRU de Toulouse - Hôpital Garonne	Toulouse cedex 9
France	CHRU de Toulouse - Hôpital Purpan	Toulouse Cedex 9
France	CHRU de Tours - Hôpital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between AUCs for PET and SPECT imaging	The difference between the AUCs (area under the curve) for PET and SPECT imaging.	1 month