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

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.

Study Overview

• Status: Completed
• Conditions: Major Depression; Elderly
• Intervention / Treatment: Drug: 18FAV45

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • University Hospital of Besançon- Jean Minjoz
  • Caen, France, 14000
    • University Hospital of Caen
  • Lille, France, 59000
    • University Hospital of Lille
  • Nice, France, 06000
    • University Hospital of Nice
  • Paris, France, 75014
    • Sainte-Anne Hospital
  • Rennes, France, 35000
    • University hospital of Rennes-Guillaume Régnier
  • Sotteville lès Rouen, France, 76300
    • Le Rouvray Hospital
  • Strasbourg, France, 67098
    • University Hospital of Strasbourg - HUS
  • Toulouse, France, 31059
    • University Hospital of Toulouse - Purpan
  • Tours, France, 37000
    • University Hospital of Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Adult 55 years or older
• Native language : french
• Study period > 7 years
• Major depression defined on the DSM-IV criteria assessed by MINI and HDRS score of 10 or over
• Affiliation to the national health insurance system
• Signed informed consent

Exclusion Criteria

• History of alcoholism or drug addiction
• MMSE less than or equal to 17
• Major depression with psychotic features
• Depressive episode resistant, patient who received two different antidepressants well conducted without significant therapeutic response
• Any current or past episode of mania, schizophrenia or any other psychotic disorder
• Any past history of stroke or Parkinson's disease
• Any current significant unstable illness
• Any past diagnosis of Alzheimer's disease
• Any current treatment by AcethylCholinesterae inhibitor, memantine or antidepressant therapy.

• Contraindications to MRI in patients with:

  1. Metallic foreign body eye.
  2. Any implanted electronic medical irremovably (pacemaker, neurostimulator, cochlear implants ...)
  3. Metal heart valve,
  4. Vascular clips formerly located on cranial aneurysm.
• Contraindications to antidepressants
• History of progressive disease that can affect the central nervous system such as uncontrolled diabetes, blood pressure greater than or equal to 180/100; chronic lung disease with hypoxia, head trauma with loss of consciousness greater than or equal to 15 minutes; brain surgery, encephalitis, recently treated cancer (<1 year), altered cerebral metabolism including subjects with stroke sequelae extended. Patients with lacunar stroke without thalamic or striatal may be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18FAV45	Drug: 18FAV45; Admnistration of 18FAV45 if patient is compliant with one of those treatment: Seroplex, Zoloft, Deroxat, Venlafaxine, Mirtazapine, Moclamine,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
standards uptakes values (SUVr)	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual cognitive deficits	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.	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Vincent Camus, University Hospital of Tours

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2012
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 11, 2013
• First Posted (Estimate): October 14, 2013

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Affective symptoms as prodromal stage of Alzheimer
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pathological Conditions, Anatomical; Depression; Depressive Disorder; Affective Symptoms; Plaque, Amyloid
• Other Study ID Numbers: PHRN10-VC/ ASAP