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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01962753
Acronym
ASAP
Enrollment
92
Registered
2013-10-14
Start date
2012-05-10
Completion date
2020-01-22
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly, Major Depression

Keywords

Affective symptoms as prodromal stage of Alzheimer

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.

Interventions

DRUG18FAV45

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

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
standards uptakes values (SUVr)2 months

Secondary

MeasureTime frameDescription
Residual cognitive deficits2 yearsThe 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORVincent CAMUS

University Hospital of Tours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026