Isotopic Imaging for Prodromal Alzheimer's Disease
ISALP
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
2 other identifiers
observational
143
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2011
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2010
CompletedFirst Posted
Study publicly available on registry
November 1, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFebruary 1, 2017
January 1, 2017
5.6 years
October 29, 2010
January 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Memory problems
Group with clinically validated memory problems
Reference group
Group without memory problems
Eligibility Criteria
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.
You may qualify if:
- patient consulting for memory problems
- caucasian
- memory complaint is validated by a clinical evaluation
- 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
You may not qualify if:
- Instrumental Activities of Daily Living (IADL): at least two items \> 1
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
CHU d'Amiens - Hôpital Sud
Amiens, 80054, France
CHU d'Angers - Hôtel-Dieu
Angers, 49933, France
CHU de Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
CHU de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076, France
APHP - Hôpital Albert Chenevier
Créteil, 94010, France
APHP - Hôpital Charles Foix
Ivry-sur-Seine, 94205, France
CHRU de Lille - Hôpital Claude Huriez
Lille, 59037, France
CHRU de Lille - Hôpital Roger Salengro
Lille, 59037, France
APHP - Hôpital Emile Roux
Limeil-Brévannes, 94456, France
APHM - Hôpital La Timone Adultes
Marseille, 13385, France
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295, France
CHU de Nancy - Hôpital Central
Nancy, 54035, France
CHU de Nice - Hôpitaux L'Archet 1 et 2
Nice, 06202, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
APHP - Hôpital Lariboisière
Paris, 75010, France
APHP - Hôpital Broca
Paris, 75013, France
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014, France
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, 75651, France
CHU de Poitiers
Poitiers, 86021, France
CHU de Reims - Hôpital Maison Blanche
Reims, 51092, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031, France
CHRU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098, France
CHRU de Toulouse - Hôpital Garonne
Toulouse, 31059, France
CHRU de Toulouse - Hôpital Purpan
Toulouse, 31059, France
CHRU de Tours - Hôpital Bretonneau
Tours, 37044, France
Biospecimen
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Olivier Kotzki, MD PhD
Centre Hospitalier Universitaire de Nîmes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2010
First Posted
November 1, 2010
Study Start
February 1, 2011
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
February 1, 2017
Record last verified: 2017-01