ElderlyASAPNCT01962753
Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)
A study testing 18FAV45 in people with Elderly and Major Depression, run by University Hospital, Tours at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Elderly, Major Depression
- What is being tested?
- 18FAV45
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 10 sitesFrance
- Study dates
- 10 May 2012to 22 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
University Hospital of Besançon- Jean Minjoz
Besançon, 25030
University Hospital of Caen
Caen, 14000
University Hospital of Lille
Lille, 59000
University Hospital of Nice
Nice, 06000
Sainte-Anne Hospital
Paris, 75014
University hospital of Rennes-Guillaume Régnier
Rennes, 35000
Le Rouvray Hospital
Sotteville-lès-Rouen, 76300
University Hospital of Strasbourg - HUS
Strasbourg, 67098
University Hospital of Toulouse - Purpan
Toulouse, 31059
University Hospital of Tours
Tours, 37000
About this study
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.
Read the 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.
- Conditions
- Elderly, Major Depression
- Being tested
- 18FAV45
- Keywords
- Affective symptoms as prodromal stage of Alzheimer
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18FAV45Drug
Admnistration of 18FAV45 if patient is compliant with one of those treatment: Seroplex, Zoloft, Deroxat, Venlafaxine, Mirtazapine, Moclamine,
| Study group | Role | What they receive |
|---|---|---|
| 18FAV45 | Experimental | Not described Receives: Drug: 18FAV45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
standards uptakes values (SUVr)
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study start10 May 2012
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent CAMUS, Principal investigator, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962753
- Sponsor's protocol ID
- PHRN10-VC/ ASAP
- Acronym
- ASAP
- Status last verified
- May 2026
- First submitted
- 10 Oct 2013
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Hage W, Vourc'h P, Gaillard P, Leger J, Belzung C, Ibarguen-Vargas Y, Andres CR, Camus V. The BDNF Val(66)Met polymorphism is associated with escitalopram response in depressed patients. Psychopharmacology (Berl). 2015 Feb;232(3):575-81. doi: 10.1007/s00213-014-3694-z. Epub 2014 Jul 31.
PubMed 25074447
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)
- ClinicalTrials.gov ID
- NCT01962753
- Acronym / sponsor ID
- ASAP / PHRN10-VC/ ASAP
- Conditions
- Elderly, Major Depression
- Keywords
- Affective symptoms as prodromal stage of Alzheimer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 10 May 2012 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18FAV45 | Experimental | Drug: 18FAV45 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18FAV45Admnistration of 18FAV45 if patient is compliant with one of those treatment: Seroplex, Zoloft, Deroxat, Venlafaxine, Mirtazapine, Moclamine, | Drug | 18FAV45 |
Primary outcome
standards uptakes values (SUVr)
Time frame: 2 months
1 secondary outcome
Residual cognitive deficits
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Results publication: PubMed 25074447El-Hage W, Vourc'h P, Gaillard P, Leger J, Belzung C, Ibarguen-Vargas Y, Andres CR, Camus V. The BDNF Val(66)Met polymorphism is associated with escitalopram response in depressed patients. Psychopharmacology (Berl). 2015 Feb;232(3):575-81. doi: 10.1007/s00213-014-3694-z. Epub 2014 Jul 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent CAMUS principal investigator
University Hospital of Tours
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18FAV45 in people with Elderly and Major Depression, run by University Hospital, Tours at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
standards uptakes values (SUVr) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.