NCT01095744

Brief 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 cortical AD (PCA and LPA). The amount of brain lesions in AD patients is estimated by:

  1. 1.measuring the rate of cortical brain atrophy,
  2. 2.FDG imaging of glucose metabolism reflecting neuronal activity, and
  3. 3.for patients who benefited from a lumbar puncture; Cortical-spinal fluid (CSF) amounts of amyloïd and tau proteins are measured.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 7, 2025

Status Verified

February 1, 2012

Enrollment Period

3.2 years

First QC Date

March 12, 2010

Last Update Submit

October 2, 2025

Conditions

Keywords

PIB imaging,brain atrophycognitive impairmentPet imagingAlzheimer's diseaseamyloid protein

Outcome Measures

Primary Outcomes (5)

  • PIB-PET imaging of amyloid load

    PET imaging using PIB radio-tracer will give an estimation of regional amyloid load for every patient

    0 - 2 months

  • FDG-PET imaging of glucose metabolism

    PET imaging using 18F-fluorodesoxyglucose (FDG) will give a visualization of regional neuronal metabolism

    0 - 2 months

  • clinical phenotypic assessment

    the clinical evaluation includes a neurologic consulting, a neuropsychologic assessment of cognitive performances, and evaluation of autonomy

    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.

    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.

    0 - 24 months after inclusion

Secondary Outcomes (1)

  • amyloid and Tau measurements in cerebro-spinal fluid (csf)

    -6 months or +6months arround T0

Study Arms (5)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • for every patients : psychiatric disorders age under18 absence of social security counter indication to MRI supposed or actual alcoholism or drug addiction pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitie Salpêtrière Hospital

Paris, Île-de-France Region, 75651, France

Location

Related Publications (3)

  • 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.

  • Migliaccio 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.

  • de 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.

Biospecimen

Retention: SAMPLES WITH DNA

DNA sample immortalized blood cell cultures csf aliquots for patients who beneficiated from a lumbar puncture.

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionAmyloidosis

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bruno Dubois, professor doctor

    INSERM U975

    PRINCIPAL INVESTIGATOR
  • marie c sarzin, doctor

    Inserm U975

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 30, 2010

Study Start

March 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 7, 2025

Record last verified: 2012-02

Locations