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Completed

NCT Number: NCT01231295

Isotopic Imaging for Prodromal Alzheimer's Disease

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Amiens - Hôpital Sud, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The difference between AUCs for PET and SPECT imaging

    Time frame: 1 month

    The difference between the AUCs (area under the curve) for PET and SPECT imaging.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: ISALP

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 1, 2010
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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