Isotopic Imaging for Prodromal Alzheimer's Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01231295

Acronym

ISALP

Enrollment

143

Registered

2010-11-01

Start date

2011-02-28

Completion date

2016-09-30

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The difference between AUCs for PET and SPECT imaging	1 month	The difference between the AUCs (area under the curve) for PET and SPECT imaging.

Countries

France

Outcome results