Isotopic Imaging for Prodromal Alzheimer's Disease (ISALP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01231295
First received: October 29, 2010
Last updated: October 9, 2014
Last verified: October 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


Enrollment: 143
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
CHU d'Amiens - Hôpital Sud
Amiens Cedex 1, France, 80054
CHU d'Angers - Hôtel-Dieu
Angers, France, 49933
CHU de Besançon - Hôpital Jean Minjoz
Besançon, France, 25030
CHU de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
APHP - Hôpital Albert Chenevier
Creteil Cedex, France, 94010
APHP - Hôpital Charles Foix
Ivry Sur Seine Cedex, France, 94205
CHRU de Lille - Hôpital Claude Huriez
Lille, France, 59037
CHRU de Lille - Hôpital Roger Salengro
Lille, France, 59037
APHP - Hôpital Emile Roux
Limeil Brevannes Cedex, France, 94456
APHM - Hôpital La Timone Adultes
Marseille cedex 5, France, 13385
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier Cedex 5, France, 34295
CHU de Nancy - Hôpital Central
Nancy, France, 54035
CHU de Nice - Hôpitaux L'Archet 1 et 2
Nice, France, 06202
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
APHP - Hôpital Broca
Paris, France, 75013
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
APHP - Hôpital Lariboisière
Paris, France, 75010
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris cedex 13, France, 75651
CHU de Poitiers
Poitiers, France, 86021
CHU de Reims - Hôpital Maison Blanche
Reims, France, 51092
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France, 76031
CHRU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
CHRU de Toulouse - Hôpital Purpan
Toulouse Cedex 9, France, 31059
CHRU de Toulouse - Hôpital Garonne
Toulouse cedex 9, France, 31059
CHRU de Tours - Hôpital Bretonneau
Tours, France, 37044
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: October 9, 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 October 19, 2014