Isotopic Imaging for Prodromal Alzheimer's Disease (ISALP)

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01231295
First received: October 29, 2010
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition
Alzheimer Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • The difference between AUCs for PET and SPECT imaging [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The difference between the AUCs (area under the curve) for PET and SPECT imaging.


Biospecimen Retention:   Samples With DNA

3 x 10ml of blood and 3 ml lumbar puncture for Abeta1-40, A1beta-42, Abetan-40, Abetan-42, sAPPalpha, Tau, pTau, and DNA extraction for the ApoE4 gene


Estimated Enrollment: 355
Study Start Date: February 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Memory problems
Group with clinically validated memory problems
Reference group
Group without memory problems

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231295

Contacts
Contact: Pierre Olivier M Kotzki, MD PhD +33.4.66.68.32.46 pierre.olivier.kotski@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU d'Amiens - Hôpital Sud Recruiting
Amiens Cedex 1, France, 80054
Sub-Investigator: Marc Etienne Meyer, MD         
Sub-Investigator: Véronique Moullart, MD         
Sub-Investigator: Lazhar Saidi, MD         
Sub-Investigator: Julie Morvan, MD         
Sub-Investigator: Isabelle El Esper, MD         
Sub-Investigator: Olivier Godefroy, MD         
CHU d'Angers - Hôtel-Dieu Recruiting
Angers, France, 49933
Sub-Investigator: Christian Jeanguillaume, MD         
Sub-Investigator: Frédérique Etcharry Bouyx, MD         
Sub-Investigator: Valérie Chauvire, MD         
CHU de Besançon - Hôpital Jean Minjoz Recruiting
Besançon, France, 25030
Sub-Investigator: Hatem Boulahdour, MD         
Sub-Investigator: Constantin Ungureanu, MD         
Sub-Investigator: Lucien Rumbach, MD         
Sub-Investigator: Eric Berger, MD         
Sub-Investigator: Pierre Vandel, MD         
CHU de Bordeaux - Groupe Hospitalier Pellegrin Recruiting
Bordeaux, France, 33076
Sub-Investigator: Michel Allard, MD         
Sub-Investigator: Jean François Dartigues, MD         
APHP - Hôpital Albert Chenevier Recruiting
Creteil Cedex, France, 94010
APHP - Hôpital Charles Foix Recruiting
Ivry Sur Seine Cedex, France, 94205
Sub-Investigator: Florence Mahieux Laurent, MD         
CHRU de Lille - Hôpital Claude Huriez Recruiting
Lille, France, 59037
Sub-Investigator: Florence Pasquier, MD PhD         
Sub-Investigator: Marc Steinling, MD         
CHRU de Lille - Hôpital Roger Salengro Recruiting
Lille, France, 59037
Sub-Investigator: Franck Semah, MD         
Sub-Investigator: Laura Ravasi, MD         
Sub-Investigator: Florence Pasquier Garguillo, MD         
Sub-Investigator: Marie Anne Mackowiak Cordoliani, MD         
Sub-Investigator: Stéphanie Bombois, MD         
Sub-Investigator: Vincent Deramecourt, MD         
Sub-Investigator: Pascaline Cassagnaud Thuillet, MD         
Sub-Investigator: Marion Paulin, MD         
APHP - Hôpital Emile Roux Recruiting
Limeil Brevannes Cedex, France, 94456
APHM - Hôpital La Timone Adultes Recruiting
Marseille cedex 5, France, 13385
Sub-Investigator: Eric Guedj, MD         
Sub-Investigator: Olivier Felician, MD         
CHU de Montpellier - Hôpital Gui de Chauliac Recruiting
Montpellier Cedex 5, France, 34295
Sub-Investigator: Jacques Touchon, MD PhD         
Sub-Investigator: Michel Zanca, MD         
CHU de Nancy - Hôpital Central Recruiting
Nancy, France, 54035
Sub-Investigator: Gilles Karcher, MD         
Sub-Investigator: Pierre-Yves Marie, MD         
Sub-Investigator: Sinan Benmahmoud, MD         
Sub-Investigator: Marie-Hélène Laurents, MD         
Sub-Investigator: Gérard Barroche, MD         
Sub-Investigator: Cosmin Alecu, MD         
CHU de Nice - Hôpitaux L'Archet 1 et 2 Recruiting
Nice, France, 06202
Sub-Investigator: Jacques Darcourt, MD PhD         
Sub-Investigator: Robert Philippe, MD         
Sub-Investigator: Renaud David, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Pierre Olivier Kotzki, MD Phd         
Sub-Investigator: Laurent Collombier, MD         
Sub-Investigator: Giovanni Castelnovo, MD         
Sub-Investigator: Denise Strubel, MD         
Sub-Investigator: Hélène Finiels, MD         
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Sub-Investigator: Lisette Volpe-Gillot, MD         
APHP - Hôpital Lariboisière Recruiting
Paris, France, 75010
Sub-Investigator: Llana Peretti, MD         
Sub-Investigator: Abdelwahab Benada, MD         
Sub-Investigator: Michèle Duet, MD         
Sub-Investigator: Claire Paquet, MD         
APHP - Hôpital Broca Recruiting
Paris, France, 75013
Sub-Investigator: Anne-Sophie Rigaud, MD         
Sub-Investigator: Galdric Orvoën, MD         
Sub-Investigator: Emmanuelle Duron Garnier, MD         
Sub-Investigator: Jean Yves Gaubert, MD         
Sub-Investigator: Hermine Lenoir, MD         
Sub-Investigator: Florian Labourée, MD         
Sub-Investigator: Florence Latour Nidier, MD         
Sub-Investigator: Catherine Bayle, MD         
Sub-Investigator: Marie Laure Seux, MD         
Sub-Investigator: Olivier Hanon, MD         
APHP - Groupe Hospitalier Pitié-Salpetrière Recruiting
Paris cedex 13, France, 75651
Sub-Investigator: Bruno Dubois, MD PhD         
Sub-Investigator: Marie-Odile Habert, MD         
Sub-Investigator: Aurélie Kas, MD         
Sub-Investigator: Nelle Daragon, MD         
Sub-Investigator: Lucette Lacomblez, MD         
Sub-Investigator: Marc Verny, MD         
Sub-Investigator: Sandrine Greffard, MD         
CHU de Poitiers Recruiting
Poitiers, France, 86021
Sub-Investigator: F Salmon, MD         
Sub-Investigator: Rémy Perdrisot, MD         
Sub-Investigator: du Boisgueheneuc, MD         
CHU de Reims - Hôpital Maison Blanche Recruiting
Reims, France, 51092
Sub-Investigator: Serge Bakchine, MD Phd         
Sub-Investigator: Dimitri Papathanassiou, Md         
Sub-Investigator: Anne Doe De Maindreville, MD         
CHU de Rouen - Hôpital Charles Nicolle Recruiting
Rouen, France, 76031
Sub-Investigator: Pierre Vera, MD         
Sub-Investigator: Agathe Edet Sanson, MD         
Sub-Investigator: Didier Hannequin, MD         
Sub-Investigator: Olivier Martinaud, MD         
Sub-Investigator: Lucie Guyant Marechal, MD         
CHRU de Strasbourg - Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Sub-Investigator: Issie Jacques Namer, MD         
Sub-Investigator: Frédéric Blanc, MD         
CHRU de Toulouse - Hôpital Garonne Recruiting
Toulouse cedex 9, France, 31059
Sub-Investigator: Bruno Vellas, MD PhD         
CHRU de Toulouse - Hôpital Purpan Recruiting
Toulouse Cedex 9, France, 31059
Sub-Investigator: Pierre Payoux, MD         
CHRU de Tours - Hôpital Bretonneau Recruiting
Tours, France, 37044
Sub-Investigator: Jean Louis Baulieu, MD         
Sub-Investigator: Caroline Hommet, MD         
Sub-Investigator: Karl Mondon, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Pierre Olivier Kotzki, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01231295     History of Changes
Other Study ID Numbers: PHRC-N/2009/POK-01, 2009-013476-53
Study First Received: October 29, 2010
Last Updated: March 4, 2014
Health Authority: France: Comité de Protection des Personnes Sud-Méditerranée III
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014