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

Elderly Clinical Trial

— ASAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962753
• Other study ID #: PHRN10-VC/ ASAP
• Status: Completed
• Phase: N/A
• Start date: May 10, 2012
• Est. completion date: January 22, 2020

Study information

• Verified date: September 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Affective Symptoms
• Depression
• Depressive Disorder
• Elderly
• Major Depression
• Plaque, Amyloid

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Besançon- Jean Minjoz	Besançon
France	University Hospital of Caen	Caen
France	University Hospital of Lille	Lille
France	University Hospital of Nice	Nice
France	Sainte-Anne Hospital	Paris
France	University hospital of Rennes-Guillaume Régnier	Rennes
France	Le Rouvray Hospital	Sotteville lès Rouen
France	University Hospital of Strasbourg - HUS	Strasbourg
France	University Hospital of Toulouse - Purpan	Toulouse
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	standards uptakes values (SUVr)		2 months
Secondary	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