Clinical trial NCT01231295: Isotopic Imaging for Prodromal Alzheimer's Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 143
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of elderly patients over 70 years of age who consult for memory problems. These patients are further split into two groups based on the clinical validation of memory complaints.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The difference between AUCs for PET and SPECT imaging
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens Cedex 1
country: France
facility: CHU d'Amiens - Hôpital Sud
city: Angers
country: France
facility: CHU d'Angers - Hôtel-Dieu
city: Besançon
country: France
facility: CHU de Besançon - Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: CHU de Bordeaux - Groupe Hospitalier Pellegrin
city: Creteil Cedex
country: France
facility: APHP - Hôpital Albert Chenevier
city: Ivry Sur Seine Cedex
country: France
facility: APHP - Hôpital Charles Foix
city: Lille
country: France
facility: CHRU de Lille - Hôpital Claude Huriez
city: Lille
country: France
facility: CHRU de Lille - Hôpital Roger Salengro
city: Limeil Brevannes Cedex
country: France
facility: APHP - Hôpital Emile Roux
city: Marseille cedex 5
country: France
facility: APHM - Hôpital La Timone Adultes
city: Montpellier Cedex 5
country: France
facility: CHU de Montpellier - Hôpital Gui de Chauliac
city: Nancy
country: France
facility: CHU de Nancy - Hôpital Central
city: Nice
country: France
facility: CHU de Nice - Hôpitaux L'Archet 1 et 2
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Paris cedex 13
country: France
facility: APHP - Groupe Hospitalier Pitié-Salpetrière
city: Paris
country: France
facility: APHP - Hôpital Lariboisière
city: Paris
country: France
facility: APHP - Hôpital Broca
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: CHU de Reims - Hôpital Maison Blanche
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: CHRU de Strasbourg - Hôpital de Hautepierre
city: Toulouse cedex 9
country: France
facility: CHRU de Toulouse - Hôpital Garonne
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôpital Purpan
city: Tours
country: France
facility: CHRU de Tours - Hôpital Bretonneau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Pierre Olivier Kotzki, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: