Alzheimer's DiseaseBIOMAGENCT01095744
Influence of Age on Amyloid Load in Alzheimer's Disease and in Atypical Focal Cortical Alzheimer's Disease
An observational study of Alzheimer's Disease and Posterior Cortical Atrophy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The first objective is to asses influence of age on amyloid load measured by PET imaging using Pittsburgh B compound (PiB) radio-tracer, in Alzheimer's disease(AD). This will allow the determination of brains age-specific deterioration factors by comparing Early onset AD (EOAD), Late onset AD (LOAD)and atypical focal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Posterior Cortical Atrophy, Logopenic Progressive Aphasia
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to May 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients have to fulfil criteria for (1)AD with an amnesic syndrome of the media-temporal type, EOAD have lower frequency and (2) and for atypical Ad respecting episodic memory, inaugural language disorder or visual-spatial disorder
Who may be able to join
- AD patients: clinical dementia rating between 0.5 and 2 free and cued recall test (Grober and Buschke) cued-recall < 18/48 and total recall < 40/48
- atypical AD : i visual-spatial disorder and respect of episodic memory progressive evolution, Balint syndrome ii progressive language disorder constituted of logopenic aphasia respect of episodic memory
- controls: age over 30 MMSE over or equal to 27 normal neuropsychiatric state for age and education level
Who cannot join
- for every patients : psychiatric disorders age under18 absence of social security counter indication to MRI supposed or actual alcoholism or drug addiction pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Age on amyloïd Load in Alzheimer's Disease and in Atypical Focal Cortical Alzheimer's Disease Like Posterior Cortical Atrophy (PCA) and Logopenic Progressive Aphasia (LPA)Using Positron Emitting Tomography (PET) Imaging
The first objective is to asses influence of age on amyloid load measured by PET imaging using Pittsburgh B compound (PiB) radio-tracer, in Alzheimer's disease(AD). This will allow the determination of brains age-specific deterioration factors by comparing Early onset AD (EOAD), Late onset AD (LOAD)and atypical focal cortical AD (PCA and LPA). The amount of brain lesions in AD patients is estimated by:
- measuring the rate of cortical brain atrophy,
- FDG imaging of glucose metabolism reflecting neuronal activity, and
- for patients who benefited from a lumbar puncture; Cortical-spinal fluid (CSF) amounts of amyloïd and tau proteins are measured.
Read the detailed description
Literature data suggests there are different types of AD depending on their age of onset, called EOAD and LOAD. These two categories are distinguished by the localization of brain atrophy : severe and 'posterior' in EOAD and more 'anterior' in LOAD. Neuro-pathologic data suggests some atypical focal cortical atrophy, characterized by a respect of episodic memory, may be classified within EOAD.
PiB-based PET imaging allows the in-vivo visualization and quantification of amyloïd load.
We want to answer the question whether the amount of amyloïd protein may be lower in LOAD than EOAD in patients showing the same level of dementia, and thus identify ageing-specific cognitive disorders and understand witch factors influence etio-pathology of typical and atypical Alzheimer's disease.
- Keywords
- PIB imaging,, brain atrophy, cognitive impairment, Pet imaging, Alzheimer's disease, amyloid protein
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EOAD typical AD | this cohort is constituted with early onset typical AD. | |
| LOAD typical | this group is constituted with late onset typical AD | |
| atypical AD | this group is constituted with atypical form of focal cortical atrophy, like posterior cortical atrophy and logopenic progressive aphasia. | |
| young controls | under 65 | |
| old controls | over 65 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIB-PET imaging of amyloid load
PET imaging using PIB radio-tracer will give an estimation of regional amyloid load for every patient
Measured: 0 - 2 months
FDG-PET imaging of glucose metabolism
PET imaging using 18F-fluorodesoxyglucose (FDG) will give a visualization of regional neuronal metabolism
Measured: 0 - 2 months
clinical phenotypic assessment
the clinical evaluation includes a neurologic consulting, a neuropsychologic assessment of cognitive performances, and evaluation of autonomy
Measured: 0 - 2 months
MRI
the magnetic resonance imaging will be performed using numerous modalities like T1 weighted sequences for anatomic information, T2 weighted FLAIR and TSE sequences to avoid vascular injuries and T2 GRE to avoid microbleeds, DTI for the diffusion tensor imaging and default mode FMRI, to identify neural networks involved in default concious mode.
Measured: 0 - 2 months
ApoE gene sequencing
ApoE gene sequencing, will be performed after all samples have been collected. So this may be 0 to 24 month after inclusion.
Measured: 0 - 24 months after inclusion
Secondary outcomes (1)
amyloid and Tau measurements in cerebro-spinal fluid (csf)
some patients have a lumbar puncture that allows a direct quantification of CSF amyloid, tau and phospho-tau amounts.This measure is performed in the 6 months following the clinical assessment (at inclusion) and when a former puncture has already been done, it can be used retro-actively up to 6 months before clinical assessment.
Measured: -6 months or +6months arround T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bruno Dubois, professor doctor, Principal investigator, INSERM U975marie c sarzin, doctor, Study chair, Inserm U975
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095744
- Sponsor's protocol ID
- C08-30
- Other IDs
- 2008-A00939-46
- Acronym
- BIOMAGE
- Status last verified
- Feb 2012
- First submitted
- 12 Mar 2010
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Dorothee G, Bottlaender M, Moukari E, de Souza LC, Maroy R, Corlier F, Colliot O, Chupin M, Lamari F, Lehericy S, Dubois B, Sarazin M, Aucouturier P. Distinct patterns of antiamyloid-beta antibodies in typical and atypical Alzheimer disease. Arch Neurol. 2012 Sep;69(9):1181-5. doi: 10.1001/archneurol.2012.604.
PubMed 22710357Migliaccio R, Agosta F, Toba MN, Samri D, Corlier F, de Souza LC, Chupin M, Sharman M, Gorno-Tempini ML, Dubois B, Filippi M, Bartolomeo P. Brain networks in posterior cortical atrophy: a single case tractography study and literature review. Cortex. 2012 Nov-Dec;48(10):1298-309. doi: 10.1016/j.cortex.2011.10.002. Epub 2011 Oct 20.
PubMed 22099855de Souza LC, Corlier F, Habert MO, Uspenskaya O, Maroy R, Lamari F, Chupin M, Lehericy S, Colliot O, Hahn-Barma V, Samri D, Dubois B, Bottlaender M, Sarazin M. Similar amyloid-beta burden in posterior cortical atrophy and Alzheimer's disease. Brain. 2011 Jul;134(Pt 7):2036-43. doi: 10.1093/brain/awr130.
PubMed 21705422
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Age on amyloïd Load in Alzheimer's Disease and in Atypical Focal Cortical Alzheimer's Disease Like Posterior Cortical Atrophy (PCA) and Logopenic Progressive Aphasia (LPA)Using Positron Emitting Tomography (PET) Imaging
- ClinicalTrials.gov ID
- NCT01095744
- Acronym / sponsor ID
- BIOMAGE / C08-30
- Keywords
- PIB imaging,, brain atrophy, cognitive impairment, Pet imaging, Alzheimer's disease, amyloid protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Mar 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Mar 2010 (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 first objective is to asses influence of age on amyloid load measured by PET imaging using Pittsburgh B compound (PiB) radio-tracer, in Alzheimer's disease(AD). This will allow the determination of brains age-specific deterioration factors by comparing Early onset AD (EOAD), Late onset AD (LOAD)and atypical focal cortical AD (PCA and LPA). The amount of brain lesions in AD patients is estimated by:
- measuring the rate of cortical brain atrophy,
- FDG imaging of glucose metabolism reflecting neuronal activity, and
- for patients who benefited from a lumbar puncture; Cortical-spinal fluid (CSF) amounts of amyloïd and tau proteins are measured.
Detailed description
Literature data suggests there are different types of AD depending on their age of onset, called EOAD and LOAD. These two categories are distinguished by the localization of brain atrophy : severe and 'posterior' in EOAD and more 'anterior' in LOAD. Neuro-pathologic data suggests some atypical focal cortical atrophy, characterized by a respect of episodic memory, may be classified within EOAD.
PiB-based PET imaging allows the in-vivo visualization and quantification of amyloïd load.
We want to answer the question whether the amount of amyloïd protein may be lower in LOAD than EOAD in patients showing the same level of dementia, and thus identify ageing-specific cognitive disorders and understand witch factors influence etio-pathology of typical and atypical Alzheimer's disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| EOAD typical AD | – | –this cohort is constituted with early onset typical AD. |
| LOAD typical | – | –this group is constituted with late onset typical AD |
| atypical AD | – | –this group is constituted with atypical form of focal cortical atrophy, like posterior cortical atrophy and logopenic progressive aphasia. |
| young controls | – | –under 65 |
| old controls | – | –over 65 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients have to fulfil criteria for (1)AD with an amnesic syndrome of the media-temporal type, EOAD have lower frequency and (2) and for atypical Ad respecting episodic memory, inaugural language disorder or visual-spatial disorder
Key inclusion criteria (3 listed)
- AD patients: clinical dementia rating between 0.5 and 2 free and cued recall test (Grober and Buschke) cued-recall < 18/48 and total recall < 40/48
- atypical AD : i visual-spatial disorder and respect of episodic memory progressive evolution, Balint syndrome ii progressive language disorder constituted of logopenic aphasia respect of episodic memory
- controls: age over 30 MMSE over or equal to 27 normal neuropsychiatric state for age and education level
Key exclusion criteria (1 listed)
- for every patients : psychiatric disorders age under18 absence of social security counter indication to MRI supposed or actual alcoholism or drug addiction pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PIB-PET imaging of amyloid load
Time frame: 0 - 2 months
PET imaging using PIB radio-tracer will give an estimation of regional amyloid load for every patient
FDG-PET imaging of glucose metabolism
Time frame: 0 - 2 months
PET imaging using 18F-fluorodesoxyglucose (FDG) will give a visualization of regional neuronal metabolism
clinical phenotypic assessment
Time frame: 0 - 2 months
the clinical evaluation includes a neurologic consulting, a neuropsychologic assessment of cognitive performances, and evaluation of autonomy
MRI
Time frame: 0 - 2 months
the magnetic resonance imaging will be performed using numerous modalities like T1 weighted sequences for anatomic information, T2 weighted FLAIR and TSE sequences to avoid vascular injuries and T2 GRE to avoid microbleeds, DTI for the diffusion tensor imaging and default mode FMRI, to identify neural networks involved in default concious mode.
ApoE gene sequencing
Time frame: 0 - 24 months after inclusion
ApoE gene sequencing, will be performed after all samples have been collected. So this may be 0 to 24 month after inclusion.
1 secondary outcome
amyloid and Tau measurements in cerebro-spinal fluid (csf)
Time frame: -6 months or +6months arround T0
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 7 Oct 2025.
- Results publication: PubMed 22710357Dorothee G, Bottlaender M, Moukari E, de Souza LC, Maroy R, Corlier F, Colliot O, Chupin M, Lamari F, Lehericy S, Dubois B, Sarazin M, Aucouturier P. Distinct patterns of antiamyloid-beta antibodies in typical and atypical Alzheimer disease. Arch Neurol. 2012 Sep;69(9):1181-5. doi: 10.1001/archneurol.2012.604.
- Results publication: PubMed 22099855Migliaccio R, Agosta F, Toba MN, Samri D, Corlier F, de Souza LC, Chupin M, Sharman M, Gorno-Tempini ML, Dubois B, Filippi M, Bartolomeo P. Brain networks in posterior cortical atrophy: a single case tractography study and literature review. Cortex. 2012 Nov-Dec;48(10):1298-309. doi: 10.1016/j.cortex.2011.10.002. Epub 2011 Oct 20.
- Results publication: PubMed 21705422de Souza LC, Corlier F, Habert MO, Uspenskaya O, Maroy R, Lamari F, Chupin M, Lehericy S, Colliot O, Hahn-Barma V, Samri D, Dubois B, Bottlaender M, Sarazin M. Similar amyloid-beta burden in posterior cortical atrophy and Alzheimer's disease. Brain. 2011 Jul;134(Pt 7):2036-43. doi: 10.1093/brain/awr130.
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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.
Bruno Dubois, professor doctor principal investigator
INSERM U975
marie c sarzin, doctor study chair
Inserm U975
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Posterior Cortical Atrophy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site 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 3 inclusion and 1 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 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
PIB-PET imaging of amyloid load (time frame: 0 - 2 months). The study lists 5 primary outcomes in all. 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 NCT01095744, which also lists 3 linked publications.
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 7 Oct 2025.