Alzheimer's DiseaseIMAPNCT01554202

Multi-modal Neuroimaging in Alzheimer's Disease

A study testing assessment of memory, circulating tPA dosage and ApoE4 in people with Alzheimer's Disease, run by University Hospital, Caen at 5 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer's Disease
What is being tested?: assessment of memory, circulating tPA dosage and ApoE4
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 295 participants
Where: 5 sitesFrance
Study dates: Jan 2008to Dec 2021
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Education level > 7 years
Native language: French
Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:
Healthy young controls: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
Healthy Middle-aged controls: between 40 and 60 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
Healthy Elderly controls: over 60 years old, living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
MCI patients: over 60 years old, presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.5 SD from the norm for age and cultural level for one or more scores of episodic memory and iii) normal performances compared to the age and the educational level of all other cognitive functions as memory, including tests to assess cognitive abilities.
Alzheimer's patients: presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery and a mild to moderate Alzheimer's disease (MMSE ≥ 15).

Who cannot join

The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
A medication that may interfere with memory or metabolic measures
A alcohol or drugs abuse
claustrophobia, metallic object in the body

Show all 9Show fewer

A predominantly left-hand (score below 50% in Edinburgh Inventory).
Protected adults, and persons not affiliated with a social security system will not participate in this study.
The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

France5 sites

University Hospital Côte de Nacre
Caen, 14033
University Hospital Roger Salengro
Lille, 59037
University Hospital Pontchaillou
Rennes, 35033
University Hospital Rouen
Rouen, 76031
University Hospital Tours
Tours, 37044

Other trials in France

About this study

Official title: Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging

According to estimations, Alzheimer's disease affects approximately 860,000 people aged of more than 65 years in France. This disease is characterized by disorders of cognitive functions, including memory, associated with structural and functional modifications of the brain. These changes are evolving within the pathology progression and can be evaluated with neuropsychological tests (to assess capabilities such as language, orientation, etc.) and also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood, nevertheless currently available treatments can slow its development if the disease is diagnosed early enough.

Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease.

The three main objectives of this project are

to identify, compare and combine predictive markers of Alzheimer's disease
to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease
to study the ability of different neuroimaging techniques to follow the evolution of this pathology.

Conditions: Alzheimer's Disease
Being tested: assessment of memory, circulating tPA dosage, ApoE4, Brain imaging examination MRI and PET examinations
Keywords: Alzheimer's disease, MCI, genetic, AV45-PET
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

assessment of memoryBehavioural
circulating tPA dosageBiological
ApoE4Genetic
Brain imaging examination MRI and PET examinationsOther

Study groups in NCT01554202
Study group	Role	What they receive
Young controls	Experimental	Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations. Receives: Behavioral: assessment of memory; Biological: circulating tPA dosage; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations
Middle age controls	Experimental	Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations. Receives: Behavioral: assessment of memory; Biological: circulating tPA dosage; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations
Elderly controls	Experimental	Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations. Receives: Behavioral: assessment of memory; Biological: circulating tPA dosage; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations
Autosomal dominant forms of early-onset Alzheimer disease	Experimental	Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations. Receives: Behavioral: assessment of memory; Biological: circulating tPA dosage; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations
Subjectif Cognitive Impariment patients	Experimental	Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations. Receives: Behavioral: assessment of memory; Biological: circulating tPA dosage; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations
Mild Cognitive Impairment patients	Experimental	Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations. Receives: Behavioral: assessment of memory; Biological: circulating tPA dosage; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations
Alzheimer Disease patients	Experimental	Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations. Receives: Behavioral: assessment of memory; Biological: circulating tPA dosage; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations
Non degenerative amnsesic syndrome	Experimental	Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations. Receives: Behavioral: assessment of memory; Biological: circulating tPA dosage; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations
Frontotemporal lobe dementia	Experimental	Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations. Receives: Behavioral: assessment of memory; Biological: circulating tPA dosage; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of volume change of whole brain, hippocampus and other structural MRI measures
Measured: 3 years
Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes
Measured: 3 years
Rates of change on each specified biochemical biomarker
Measured: 3 years
Rates of change of glucose metabolism (FDG-PET)
Measured: 3 years
Extent of amyloid deposition as measured by 18F-AV45
Measured: 3 years
Group differences for each imaging and biomarker measurement
Measured: 3 years
APOE genotype
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Dec 2021

First posted14 Mar 2012 (estimated)
Study startJan 2008
Primary completionDec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)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 University Hospital, CaenThe 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: 295 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01554202
Sponsor's protocol ID: 2007-A00414-49
Acronym: IMAP
Status last verified: Mar 2013
First submitted: 13 Mar 2012
Last updated: 6 Mar 2013
Results posted: No
Data monitoring committee: Yes

Publications

Chetelat G. [Neuroimaging Alzheimer's disease: early diagnosis, monitoring, and mechanism understanding]. Med Sci (Paris). 2011 Feb;27(2):193-8. doi: 10.1051/medsci/2011272193. Epub 2011 Mar 8. French.
PubMed 21382329
Mevel K, Grassiot B, Chetelat G, Defer G, Desgranges B, Eustache F. [The default mode network: cognitive role and pathological disturbances]. Rev Neurol (Paris). 2010 Nov;166(11):859-72. doi: 10.1016/j.neurol.2010.01.008. Epub 2010 Mar 11. French.
PubMed 20226489
La Joie R, Fouquet M, Mezenge F, Landeau B, Villain N, Mevel K, Pelerin A, Eustache F, Desgranges B, Chetelat G. Differential effect of age on hippocampal subfields assessed using a new high-resolution 3T MR sequence. Neuroimage. 2010 Nov 1;53(2):506-14. doi: 10.1016/j.neuroimage.2010.06.024. Epub 2010 Jun 16.
PubMed 20600996
Villain N, Landeau B, Groussard M, Mevel K, Fouquet M, Dayan J, Eustache F, Desgranges B, Chetelat G. A simple way to improve anatomical mapping of functional brain imaging. J Neuroimaging. 2010 Oct;20(4):324-33. doi: 10.1111/j.1552-6569.2010.00470.x.
PubMed 20331499

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Assessing Treatment With High-phenolic EVOO Supplements for Neurovascular Activity
Mild Cognitive Impairment (MCI)
Active, not recruiting
Effectiveness of Strength-based Intervention for Elderly With Dementia Living in the Community
Dementia, Mild Cognitive Impairment

All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging
ClinicalTrials.gov ID: NCT01554202
Acronym / sponsor ID: IMAP / 2007-A00414-49
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease, MCI, genetic, AV45-PET
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 295 participants (estimated)
Lead sponsor: University Hospital, CaenUniversity, hospital or other
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Study start: Jan 2008
Primary completion: Dec 2021 (estimated)
First posted: 14 Mar 2012 (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.

Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease.

The three main objectives of this project are

to identify, compare and combine predictive markers of Alzheimer's disease
to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease
to study the ability of different neuroimaging techniques to follow the evolution of this pathology.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Young controls	Experimental	Behavioral: assessment of memory, Biological: circulating tPA dosage, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinationsAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Middle age controls	Experimental	Behavioral: assessment of memory, Biological: circulating tPA dosage, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinationsAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Elderly controls	Experimental	Behavioral: assessment of memory, Biological: circulating tPA dosage, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinationsAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Autosomal dominant forms of early-onset Alzheimer disease	Experimental	Behavioral: assessment of memory, Biological: circulating tPA dosage, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinationsAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Subjectif Cognitive Impariment patients	Experimental	Behavioral: assessment of memory, Biological: circulating tPA dosage, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinationsAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Mild Cognitive Impairment patients	Experimental	Behavioral: assessment of memory, Biological: circulating tPA dosage, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinationsAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Alzheimer Disease patients	Experimental	Behavioral: assessment of memory, Biological: circulating tPA dosage, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinationsAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Non degenerative amnsesic syndrome	Experimental	Behavioral: assessment of memory, Biological: circulating tPA dosage, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinationsAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Frontotemporal lobe dementia	Experimental	Behavioral: assessment of memory, Biological: circulating tPA dosage, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinationsAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Education level > 7 years
Native language: French
Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:

Key exclusion criteria (9 listed)

The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
A medication that may interfere with memory or metabolic measures
A alcohol or drugs abuse

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
assessment of memory	Behavioural	Alzheimer Disease patients, Autosomal dominant forms of early-onset Alzheimer disease, Elderly controls, Frontotemporal lobe dementia, Middle age controls, Mild Cognitive Impairment patients, Non degenerative amnsesic syndrome, Subjectif Cognitive Impariment patients, Young controls
circulating tPA dosage	Biological	Alzheimer Disease patients, Autosomal dominant forms of early-onset Alzheimer disease, Elderly controls, Frontotemporal lobe dementia, Middle age controls, Mild Cognitive Impairment patients, Non degenerative amnsesic syndrome, Subjectif Cognitive Impariment patients, Young controls
ApoE4	Genetic	Alzheimer Disease patients, Autosomal dominant forms of early-onset Alzheimer disease, Elderly controls, Frontotemporal lobe dementia, Middle age controls, Mild Cognitive Impairment patients, Non degenerative amnsesic syndrome, Subjectif Cognitive Impariment patients, Young controls
Brain imaging examination MRI and PET examinations	Other	Alzheimer Disease patients, Autosomal dominant forms of early-onset Alzheimer disease, Elderly controls, Frontotemporal lobe dementia, Middle age controls, Mild Cognitive Impairment patients, Non degenerative amnsesic syndrome, Subjectif Cognitive Impariment patients, Young controls

Primary outcome

Rate of volume change of whole brain, hippocampus and other structural MRI measures
Time frame: 3 years
Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes
Time frame: 3 years
Rates of change on each specified biochemical biomarker
Time frame: 3 years
Rates of change of glucose metabolism (FDG-PET)
Time frame: 3 years
Extent of amyloid deposition as measured by 18F-AV45
Time frame: 3 years
Group differences for each imaging and biomarker measurement
Time frame: 3 years
APOE genotype
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 6 Mar 2013.
Background: PubMed 21382329Chetelat G. [Neuroimaging Alzheimer's disease: early diagnosis, monitoring, and mechanism understanding]. Med Sci (Paris). 2011 Feb;27(2):193-8. doi: 10.1051/medsci/2011272193. Epub 2011 Mar 8. French.
Background: PubMed 20226489Mevel K, Grassiot B, Chetelat G, Defer G, Desgranges B, Eustache F. [The default mode network: cognitive role and pathological disturbances]. Rev Neurol (Paris). 2010 Nov;166(11):859-72. doi: 10.1016/j.neurol.2010.01.008. Epub 2010 Mar 11. French.
Results publication: PubMed 20600996La Joie R, Fouquet M, Mezenge F, Landeau B, Villain N, Mevel K, Pelerin A, Eustache F, Desgranges B, Chetelat G. Differential effect of age on hippocampal subfields assessed using a new high-resolution 3T MR sequence. Neuroimage. 2010 Nov 1;53(2):506-14. doi: 10.1016/j.neuroimage.2010.06.024. Epub 2010 Jun 16.
Results publication: PubMed 20331499Villain N, Landeau B, Groussard M, Mevel K, Fouquet M, Dayan J, Eustache F, Desgranges B, Chetelat G. A simple way to improve anatomical mapping of functional brain imaging. J Neuroimaging. 2010 Oct;20(4):324-33. doi: 10.1111/j.1552-6569.2010.00470.x.

Related trials for Alzheimer's Disease

RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Assessing Treatment With High-phenolic EVOO Supplements for Neurovascular Activity
Mild Cognitive Impairment (MCI)
Active, not recruiting
Effectiveness of Strength-based Intervention for Elderly With Dementia Living in the Community
Dementia, Mild Cognitive Impairment

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.

Vincent de La Sayette, MD principal investigator

University Hospital, Caen

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing assessment of memory, circulating tPA dosage and ApoE4 in people with Alzheimer's Disease, run by University Hospital, Caen at 5 sites 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 8 inclusion and 9 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 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Results are not available in the source record.

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?

Rate of volume change of whole brain, hippocampus and other structural MRI measures (time frame: 3 years). The study lists 7 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 NCT01554202, which also lists 4 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 6 Mar 2013.