Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)

Not Applicable

Completed

• Conditions: Elderly; Major Depression
• Interventions: Drug: 18FAV45

• Registration Number: NCT01962753
• Lead Sponsor: University Hospital, Tours

Brief Summary

The primary objective of the study is to compare the brain amyloid load in fully, partially and non remitting depressed elderly patients at 8 weeks of antidepressant therapy, by using PET with \[F18\]AV45.

Detailed Description

The main aim of this study is to assess the brain amyloid load in treated depressed elderly subjects using PET with \[F18\]AV45. The investigators hypothesize that the brain amyloid load will be higher in non or partially remitting depressed subjects treated with antidepressants than in fully remitting ones. An additional two years follow-up will allow comparing the brain amyloid load at baseline between those who will have evolved towards MCI or MA and those who will not, including ApoE genotype, the cognitive performances at baseline, the hippocampus volume as assessed by MRI, the type and profile of mood disorder (number of past episodes, age at first episode, vascular risk factor profile, response profile to antidepressants), as covariates.

Study Timeline

• Study Start: 2012-05-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-14
• Primary Completion: 2020-01-22
• Study Completion: 2020-01-22
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18FAV45	18FAV45	-

Primary Outcome Measures

Name	Time	Method
standards uptakes values (SUVr)	2 months

Secondary Outcome Measures

Name	Time	Method
Residual cognitive deficits	2 years	The residual cognitive deficits (presence/absence) will be considered as a categorical variable.; The ApoE genotype will also be considered as categorical variables, as well as vascular risk factor profile, WMH at MRI. MADRS, NPI and IA scores as well as the hippocampus volume will be considered as continuous variables.

Trial Locations

Locations (10)

University Hospital of Besançon- Jean Minjoz; 🇫🇷 Besançon, France

University Hospital of Lille; 🇫🇷 Lille, France

University Hospital of Nice; 🇫🇷 Nice, France

Sainte-Anne Hospital; 🇫🇷 Paris, France

University Hospital of Strasbourg - HUS; 🇫🇷 Strasbourg, France

Le Rouvray Hospital; 🇫🇷 Sotteville lès Rouen, France

University hospital of Rennes-Guillaume Régnier; 🇫🇷 Rennes, France

University Hospital of Tours; 🇫🇷 Tours, France

University Hospital of Toulouse - Purpan; 🇫🇷 Toulouse, France

University Hospital of Caen; 🇫🇷 Caen, France