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

NCT01962753 | Completed DMC

• 1 other identifier: PHRN10-VC/ ASAP
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 10

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.

Conditions

Elderly; Major Depression

Keywords

Affective symptoms as prodromal stage of Alzheimer

Outcome Measures

Primary Outcomes (1)

• standards uptakes values (SUVr)

  2 months

Secondary Outcomes (1)

• Residual cognitive deficits

  2 years

Study Arms (1)

18FAV45

EXPERIMENTAL

Drug: 18FAV45

Interventions

18FAV45 DRUG

Admnistration of 18FAV45 if patient is compliant with one of those treatment: Seroplex, Zoloft, Deroxat, Venlafaxine, Mirtazapine, Moclamine,

18FAV45

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Metallic foreign body eye.
• Any implanted electronic medical irremovably (pacemaker, neurostimulator, cochlear implants ...)
• Metal heart valve,
• Vascular clips formerly located on cranial aneurysm.
• Contraindications to antidepressants

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (10)

University Hospital of Besançon- Jean Minjoz

Besançon, 25030, France

Location

University Hospital of Caen

Caen, 14000, France

Location

University Hospital of Lille

Lille, 59000, France

Location

University Hospital of Nice

Nice, 06000, France

Location

Sainte-Anne Hospital

Paris, 75014, France

Location

University hospital of Rennes-Guillaume Régnier

Rennes, 35000, France

Location

Le Rouvray Hospital

Sotteville-lès-Rouen, 76300, France

Location

University Hospital of Strasbourg - HUS

Strasbourg, 67098, France

Location

University Hospital of Toulouse - Purpan

Toulouse, 31059, France

Location

University Hospital of Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Vincent CAMUS

  University Hospital of Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 14, 2013
• Study Start: May 10, 2012
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

FR (10)