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Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Clinic and neuropsychologic evaluation

MRI

PET

Apolipoprotein E genotyping

Study of cerebrospinal fluid

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring subjects developing symptoms of Alzheimer Disease

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Arm Alzheimer Disease : first symptoms from 1 to 5 years before the inclusion, Clinical Dementia Rating = 1, efficient contraception for women
Arm Control : efficient contraception for women

Exclusion Criteria:

Important general disease : diabetes, neoplasia, alcoholism
First symptoms less than 1 year or more than 5 years before the inclusion
Pregnancy, breast feeding

Sites / Locations

Assistance Publique - Hôpitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alzheimer Disease

Control

Arm Description

subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old

subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.

Outcomes

Primary Outcome Measures

to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting.

Secondary Outcome Measures

to describe for each age group, and in particular for the younger patient group, the functional impact of disability in everyday life on both, patients and caregivers.

Full Information

NCT ID

NCT00987090

First Posted

September 29, 2009

Last Updated

October 22, 2015

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT00987090

Brief Title

Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)

Official Title

Early-onset and Late-onset Sporadic Alzheimer's Disease (AD) : Variations of the Clinical Profile and Paraclinical Features Depending on the Age at the Onset of Clinical Signs

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Alzheimer's disease (AD) is usually associated with aging, age being the principal identified risk factor. However, younger subjects also develop AD and the prevalence of early onset AD is unknown. It is estimated that about 30 000 subjects develop symptoms of AD before the age of 65 in France. There is evidence that early onset AD differs from AD in older patients. In particular, clinical and neuroimaging studies suggest early involvement of neocortical brain regions and their functions in early onset AD, while mediotemporal areas and memory might be more involved in late onset AD. These differences could partly explain the atypical clinical and imaging features of younger patients, the diagnostic difficulties in these patients and the specific problems related to medical care of this age group. The present study uses a multidisciplinary approach with longitudinal followup in order to establish the impact of age on the clinical and neuroimaging picture of sporadic AD in a multicentric setting. Another aim of the project is to describe for each age group, and in particular for the younger patient group, the functional impact of disability in everyday life on both, patients and caregivers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

subjects developing symptoms of Alzheimer Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alzheimer Disease

Arm Type

Active Comparator

Arm Description

subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.

Intervention Type

Biological

Intervention Name(s)

Clinic and neuropsychologic evaluation

Intervention Description

evaluation at the inclusion and 18 months after

Intervention Type

Radiation

Intervention Name(s)

MRI

Intervention Description

intervention at the inclusion and 18 months after

Intervention Type

Procedure

Intervention Name(s)

PET

Intervention Description

18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after.

Intervention Type

Biological

Intervention Name(s)

Apolipoprotein E genotyping

Intervention Description

genotyping at the inclusion

Intervention Type

Biological

Intervention Name(s)

Study of cerebrospinal fluid

Intervention Description

intervention at the inclusion

Primary Outcome Measure Information:

Title

to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

to describe for each age group, and in particular for the younger patient group, the functional impact of disability in everyday life on both, patients and caregivers.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Arm Alzheimer Disease : first symptoms from 1 to 5 years before the inclusion, Clinical Dementia Rating = 1, efficient contraception for women Arm Control : efficient contraception for women Exclusion Criteria: Important general disease : diabetes, neoplasia, alcoholism First symptoms less than 1 year or more than 5 years before the inclusion Pregnancy, breast feeding

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mathieu Ceccaldi

mathieu.ceccaldi@ap-hm.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

mathieu ceccaldi

Organizational Affiliation

Assistance Publique - Hôpitaux de Marseille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assistance Publique - Hôpitaux de Marseille

City

Marseille

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathieu Ceccaldi

mathieu.ceccaldi@ap-hm.fr

First Name & Middle Initial & Last Name & Degree

Mathieu Ceccaldi

12. IPD Sharing Statement

Learn more about this trial

Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)

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