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

Primary Purpose

Elderly, Major Depression

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18FAV45
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Elderly focused on measuring Affective symptoms as prodromal stage of Alzheimer

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Besançon- Jean Minjoz
  • University Hospital of Caen
  • University Hospital of Lille
  • University Hospital of Nice
  • Sainte-Anne Hospital
  • University hospital of Rennes-Guillaume Régnier
  • Le Rouvray Hospital
  • University Hospital of Strasbourg - HUS
  • University Hospital of Toulouse - Purpan
  • University Hospital of Tours

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18FAV45

Arm Description

Outcomes

Primary Outcome Measures

standards uptakes values (SUVr)

Secondary Outcome Measures

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.

Full Information

First Posted
October 10, 2013
Last Updated
September 8, 2022
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT01962753
Brief Title
Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)
Acronym
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2012 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Major Depression
Keywords
Affective symptoms as prodromal stage of Alzheimer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18FAV45
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
18FAV45
Intervention Description
Admnistration of 18FAV45 if patient is compliant with one of those treatment: Seroplex, Zoloft, Deroxat, Venlafaxine, Mirtazapine, Moclamine,
Primary Outcome Measure Information:
Title
standards uptakes values (SUVr)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Residual cognitive deficits
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent CAMUS
Organizational Affiliation
University Hospital of Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Besançon- Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
University Hospital of Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
University Hospital of Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
University Hospital of Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Sainte-Anne Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
University hospital of Rennes-Guillaume Régnier
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Le Rouvray Hospital
City
Sotteville lès Rouen
ZIP/Postal Code
76300
Country
France
Facility Name
University Hospital of Strasbourg - HUS
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
University Hospital of Toulouse - Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

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

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