Clinical trial NCT01962753: Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)
Official title: Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Major Depression
Keywords: Affective symptoms as prodromal stage of Alzheimer
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 92
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: standards uptakes values (SUVr)
timeFrame: 2 months
Secondary outcomes:
measure: Residual cognitive deficits
timeFrame: 2 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital of Besançon- Jean Minjoz
city: Caen
country: France
facility: University Hospital of Caen
city: Lille
country: France
facility: University Hospital of Lille
city: Nice
country: France
facility: University Hospital of Nice
city: Paris
country: France
facility: Sainte-Anne Hospital
city: Rennes
country: France
facility: University hospital of Rennes-Guillaume Régnier
city: Sotteville lès Rouen
country: France
facility: Le Rouvray Hospital
city: Strasbourg
country: France
facility: University Hospital of Strasbourg - HUS
city: Toulouse
country: France
facility: University Hospital of Toulouse - Purpan
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: University Hospital of Tours
name: Vincent CAMUS
role: PRINCIPAL_INVESTIGATOR
References: