Alzheimer's DiseaseNCT00987090
Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)
A study testing Clinic and neuropsychologic evaluation, MRI and PET in people with Alzheimer's Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Clinic and neuropsychologic evaluation, MRI and PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Sep 2016
- 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 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Important general disease : diabetes, neoplasia, alcoholism
- First symptoms less than 1 year or more than 5 years before the inclusion
- Pregnancy, breast feeding
Trial locations and contacts
1 site in 1 country.
Mathieu Ceccaldi contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Marseille
Marseille, France
Mathieu Ceccaldi, mathieu.ceccaldi@ap-hm.fr
Mathieu Ceccaldi
About this study
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
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.
- Conditions
- Alzheimer's Disease
- Being tested
- Clinic and neuropsychologic evaluation, MRI, PET, Apolipoprotein E genotyping, Study of cerebrospinal fluid
- Keywords
- subjects developing symptoms of Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic and neuropsychologic evaluationBiological
evaluation at the inclusion and 18 months after
MRIRadiation
intervention at the inclusion and 18 months after
PETProcedure or surgery
18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after.
Apolipoprotein E genotypingBiological
genotyping at the inclusion
Study of cerebrospinal fluidBiological
intervention at the inclusion
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer Disease | Active comparator | subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old Receives: Biological: Clinic and neuropsychologic evaluation; Radiation: MRI; Procedure: PET; Biological: Apolipoprotein E genotyping; Biological: Study of cerebrospinal fluid |
| Control | Placebo comparator | subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old. Receives: Biological: Clinic and neuropsychologic evaluation; Radiation: MRI; Procedure: PET; Biological: Apolipoprotein E genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mathieu ceccaldi, Principal investigator, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987090
- Sponsor's protocol ID
- 2008/24
- Other IDs
- 2008-A01213-52
- Status last verified
- Oct 2015
- First submitted
- 29 Sep 2009
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00987090
- Acronym / sponsor ID
- 2008/24
- Conditions
- Alzheimer's Disease
- Keywords
- subjects developing symptoms of Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2016 (estimated)
- First posted
- 30 Sep 2009 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer Disease | Active comparator | Biological: Clinic and neuropsychologic evaluation, Radiation: MRI, Procedure: PET, Biological: Apolipoprotein E genotyping, Biological: Study of cerebrospinal fluidsubjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old |
| Control | Placebo comparator | Biological: Clinic and neuropsychologic evaluation, Radiation: MRI, Procedure: PET, Biological: Apolipoprotein E genotypingsubjects without symptoms of Alzheimer Disease aged from 45 to 85 years old. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Important general disease : diabetes, neoplasia, alcoholism
- First symptoms less than 1 year or more than 5 years before the inclusion
- Pregnancy, breast feeding
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 |
|---|---|---|
| Clinic and neuropsychologic evaluationevaluation at the inclusion and 18 months after | Biological | Alzheimer Disease, Control |
| MRIintervention at the inclusion and 18 months after | Radiation | Alzheimer Disease, Control |
| PET18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after. | Procedure or surgery | Alzheimer Disease, Control |
| Apolipoprotein E genotypinggenotyping at the inclusion | Biological | Alzheimer Disease, Control |
| Study of cerebrospinal fluidintervention at the inclusion | Biological | Alzheimer Disease |
Primary outcome
to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting.
Time frame: 3 years
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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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.
Mathieu Ceccaldi contact
mathieu ceccaldi principal investigator
Assistance Publique - Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic and neuropsychologic evaluation, MRI and PET in people with Alzheimer's Disease, run by Assistance Publique Hopitaux De Marseille 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Oct 2015. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu Ceccaldi (mathieu.ceccaldi@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2015.