Alzheimer's DiseaseNCT00684281
Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment
A study testing Neurological and neuropsychological consultation, MRI and Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA in people with Alzheimer's Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The aim of this project is to follow cohort of patients with aMCI in order to establish whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory profiles and profiles of mesiotemporal atrophy and metabolic change Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Neurological and neuropsychological consultation, MRI and Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Dec 2011
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients beforehand include in the PHRC 2001 study (These patients presented to the inclusion in the PHRC 2001 a qualified board of amnestic Mild Cognitive Impairment [aMCI] or light cognitive confusion of type amnestic)
- The patient must be affiliated to an insurance scheme disease to participate in this study
Who cannot join
- For the magnetic resonance imaging: usual contraindications for an examination by MRI: claustrophobia, metal foreign bodies, pacemakers, etc.
- Incapacitated to realize the neuropsychological evaluation because of medical intercurrentes disorders
- Appointment of a guardian
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital de la Timone- Service de neurologie et de neuropsychologie
Marseille, 13005
About this study
The aim of this project is to follow cohort of patients with aMCI in order to establish whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory profiles and profiles of mesiotemporal atrophy and metabolic change
Read the detailed description
The syndrome of "amnestic Mild Cognitive Impairment" (aMCI) has been introduced for patients with intact activities of daily living, with a memory complaint and objective memory decline on neuropathological assessment, without significative change in other domains of cognition. Follow-up in these patients shows that the memory impairment may remain stable or improve, while it worsens or extends to other cognitive domains in others, indicating prodromal AD.
- Conditions
- Alzheimer's Disease
- Being tested
- Neurological and neuropsychological consultation, MRI, Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological and neuropsychological consultation, MRIOther
Neurological and neuropsychological consultation, MRI for the month 0, 18 and 36
Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNAOther
Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA, months 0/18/36
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Subject control Receives: Other: Neurological and neuropsychological consultation, MRI |
| 2 | Experimental | 40 patients before hand include in a program Receives: Other: Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis
Measured: 36 months
Characterize the clinical evolution of these subjects: escalation with appearance of an insanity (of type Alzheimer's disease or of another type: degenerations fronto-temporal, insanity with body of Lewy), stabilization even improvement.
Measured: 36 months
Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict an escalation
Measured: 36 months
Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict a stabilization or an improvement.
Measured: 36 months
Improve the state of the knowledge on the origin of the confusions mnésiques isolated at the persons of fifty and more years old.
Measured: 36 months
Secondary outcomes (5)
Establish diagnostic criteria which allow to improve the sensibility and the specificity of the premature diagnosis of MY.
Measured: 36 months
Determine if the ultra-premature diagnosis of MY at a stage where the hurts are still confined in the structures under - hippocampiques is possible.
Measured: 36 months
Determine the specific character or not of the infringement of the memory of visual recognition in the novice Alzheimer's disease.
Measured: 36 months
Determine the specific character or not the atrophy and the metabolic modifications of regions under - hippocampiques in the novice Alzheimer's disease.
Measured: 36 months
Inform the existence of process of functional compensation in the population of aMCI, notably to those who show themselves stable or improve.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2011
- Study completionDec 2011
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu CECCALDI, MD, Principal investigator, Assistance Publique des Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684281
- Sponsor's protocol ID
- 2007-A00851-52
- Other IDs
- 2007-27
- Status last verified
- Aug 2014
- First submitted
- 21 May 2008
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment
- ClinicalTrials.gov ID
- NCT00684281
- Acronym / sponsor ID
- 2007-A00851-52
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 May 2008 (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 aim of this project is to follow cohort of patients with aMCI in order to establish whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory profiles and profiles of mesiotemporal atrophy and metabolic change
Detailed description
The syndrome of "amnestic Mild Cognitive Impairment" (aMCI) has been introduced for patients with intact activities of daily living, with a memory complaint and objective memory decline on neuropathological assessment, without significative change in other domains of cognition. Follow-up in these patients shows that the memory impairment may remain stable or improve, while it worsens or extends to other cognitive domains in others, indicating prodromal AD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Neurological and neuropsychological consultation, MRISubject control |
| 2 | Experimental | Other: Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA40 patients before hand include in a program |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients beforehand include in the PHRC 2001 study (These patients presented to the inclusion in the PHRC 2001 a qualified board of amnestic Mild Cognitive Impairment [aMCI] or light cognitive confusion of type amnestic)
- The patient must be affiliated to an insurance scheme disease to participate in this study
Key exclusion criteria (3 listed)
- For the magnetic resonance imaging: usual contraindications for an examination by MRI: claustrophobia, metal foreign bodies, pacemakers, etc.
- Incapacitated to realize the neuropsychological evaluation because of medical intercurrentes disorders
- Appointment of a guardian
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 |
|---|---|---|
| Neurological and neuropsychological consultation, MRINeurological and neuropsychological consultation, MRI for the month 0, 18 and 36 | Other | 1 |
| Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNANeurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA, months 0/18/36 | Other | 2 |
Primary outcome
Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis
Time frame: 36 months
Characterize the clinical evolution of these subjects: escalation with appearance of an insanity (of type Alzheimer's disease or of another type: degenerations fronto-temporal, insanity with body of Lewy), stabilization even improvement.
Time frame: 36 months
Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict an escalation
Time frame: 36 months
Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict a stabilization or an improvement.
Time frame: 36 months
Improve the state of the knowledge on the origin of the confusions mnésiques isolated at the persons of fifty and more years old.
Time frame: 36 months
5 secondary outcomes
Establish diagnostic criteria which allow to improve the sensibility and the specificity of the premature diagnosis of MY.
Time frame: 36 months
Determine if the ultra-premature diagnosis of MY at a stage where the hurts are still confined in the structures under - hippocampiques is possible.
Time frame: 36 months
Determine the specific character or not of the infringement of the memory of visual recognition in the novice Alzheimer's disease.
Time frame: 36 months
Determine the specific character or not the atrophy and the metabolic modifications of regions under - hippocampiques in the novice Alzheimer's disease.
Time frame: 36 months
Inform the existence of process of functional compensation in the population of aMCI, notably to those who show themselves stable or improve.
Time frame: 36 months
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 28 Aug 2014.
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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.
Matthieu CECCALDI, MD principal investigator
Assistance Publique des Hopitaux 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 Neurological and neuropsychological consultation, MRI and Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA 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: finished, as of the sponsor's last update on 28 Aug 2014. 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?
Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis (time frame: 36 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?
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 28 Aug 2014.