Isotopic Imaging for Prodromal Alzheimer's Disease

NCT ID: NCT01231295

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Memory problems

Group with clinically validated memory problems

No interventions assigned to this group

Reference group

Group without memory problems

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Olivier Kotzki, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU d'Amiens - Hôpital Sud

Amiens, , France

Site Status

CHU d'Angers - Hôtel-Dieu

Angers, , France

Site Status

CHU de Besançon - Hôpital Jean Minjoz

Besançon, , France

Site Status

CHU de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, , France

Site Status

APHP - Hôpital Albert Chenevier

Créteil, , France

Site Status

APHP - Hôpital Charles Foix

Ivry-sur-Seine, , France

Site Status

CHRU de Lille - Hôpital Claude Huriez

Lille, , France

Site Status

CHRU de Lille - Hôpital Roger Salengro

Lille, , France

Site Status

APHP - Hôpital Emile Roux

Limeil-Brévannes, , France

Site Status

APHM - Hôpital La Timone Adultes

Marseille, , France

Site Status

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, , France

Site Status

CHU de Nancy - Hôpital Central

Nancy, , France

Site Status

CHU de Nice - Hôpitaux L'Archet 1 et 2

Nice, , France

Site Status

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

APHP - Hôpital Lariboisière

Paris, , France

Site Status

APHP - Hôpital Broca

Paris, , France

Site Status

Groupe Hospitalier Paris Saint-Joseph

Paris, , France

Site Status

APHP - Groupe Hospitalier Pitié-Salpetrière

Paris, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

CHU de Reims - Hôpital Maison Blanche

Reims, , France

Site Status

CHU de Rouen - Hôpital Charles Nicolle

Rouen, , France

Site Status

CHRU de Strasbourg - Hôpital de Hautepierre

Strasbourg, , France

Site Status

CHRU de Toulouse - Hôpital Garonne

Toulouse, , France

Site Status

CHRU de Toulouse - Hôpital Purpan

Toulouse, , France

Site Status

CHRU de Tours - Hôpital Bretonneau

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2009-013476-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PHRC-N/2009/POK-01

Identifier Type: -

Identifier Source: org_study_id

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