Alzheimer DiseaseIMPRONCT01638884
Prospective Memory Imaging
A study testing Memory assessment, Structural MRI and Functional MRI in people with Alzheimer Disease, run by University Hospital, Caen at 3 sites in France.
Trial summary
The purpose of this study is to investigate prospective merory (memory of intentions) in healthy controls and in aMCI (amnestic Mild Cognitive Impairment) and AD (Alzheimer Disease) patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Memory assessment, Structural MRI and Functional MRI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2010to Jun 2015
- 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
- Beck < 7
- Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:
- Young Healthy Subjects: between 18 and 44 years old;
- Middle age Healthy Subjects: between 45 and 69 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery.
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- Elderly Healthy Subjects: over 70 years old, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery.
- MCI patients: over 50 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 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: over 50 years old, 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 ≥ 18).
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 (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
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- 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.
- Pregnant or suckling women
- The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)
Trial locations and contacts
3 sites in 1 country.
France3 sites, 1 recruiting
- Active, not recruiting
GIP Cyceron
Caen, Calvados, 14000
- Active, not recruiting
MRSH - University of Caen
Caen, Calvados, 14000
- Recruiting
University Hospital Côte de Nacre
Caen, 14033
About this study
Official title: Cerebral Substrates of Prospective Memory in Healthy Young Adults and Disruptions in Normal Aging and Alzheimer Disease: a Study in Anatomical, Functional and Diffusion Tensor MRI.
The purpose of this study is to investigate prospective merory (memory of intentions) in healthy controls and in aMCI (amnestic Mild Cognitive Impairment) and AD (Alzheimer Disease) patients.
- Conditions
- Alzheimer Disease
- Being tested
- Memory assessment, Structural MRI, Functional MRI, Virtual reality / Memory assessment
- Keywords
- Prospective Memory, Healthy Aging, Alzheimer Disease, Brain Imaging
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory assessmentBehavioural
Neuropsychological tests including clinical and original tests to compare differences between each populations
Structural MRIOther
to compare differences between each populations
Functional MRIOther
to compare differences between each populations
Virtual reality / Memory assessmentOther
to compare differences between each populations
| Study group | Role | What they receive |
|---|---|---|
| Young Healthy Subjects | Experimental | Not described Receives: Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment |
| Middle age Healthy Subjects | Experimental | Not described Receives: Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment |
| Elderly Healthy Subjects | Experimental | Not described Receives: Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment |
| Mild Cognitive Impairment patients | Experimental | Not described Receives: Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment |
| Alzheimer Disease patients | Experimental | Not described Receives: Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of volume change of whole brain and other structural MRI measures
Measured: 1 Month
Cerebral regions implicated in prospective memory observed by functional MRI
Measured: 1 Month
Episodic memory as measured by Cognitive Tests
Measured: 18 Months
Virtual reality evaluation of prospective memory
Measured: 1 Month
Group differences for each imaging and neuropsychological measurement
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startSep 2010
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent de La Sayette, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638884
- Sponsor's protocol ID
- 2010-A00031-38
- Acronym
- IMPRO
- Status last verified
- Apr 2014
- First submitted
- 10 Jul 2012
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Substrates of Prospective Memory in Healthy Young Adults and Disruptions in Normal Aging and Alzheimer Disease: a Study in Anatomical, Functional and Diffusion Tensor MRI.
- ClinicalTrials.gov ID
- NCT01638884
- Acronym / sponsor ID
- IMPRO / 2010-A00031-38
- Conditions
- Alzheimer Disease
- Keywords
- Prospective Memory, Healthy Aging, Alzheimer Disease, Brain Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Sep 2010
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 12 Jul 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.
The purpose of this study is to investigate prospective merory (memory of intentions) in healthy controls and in aMCI (amnestic Mild Cognitive Impairment) and AD (Alzheimer Disease) patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Young Healthy Subjects | Experimental | Behavioral: Memory assessment, Other: Structural MRI, Other: Functional MRI, Other: Virtual reality / Memory assessment |
| Middle age Healthy Subjects | Experimental | Behavioral: Memory assessment, Other: Structural MRI, Other: Functional MRI, Other: Virtual reality / Memory assessment |
| Elderly Healthy Subjects | Experimental | Behavioral: Memory assessment, Other: Structural MRI, Other: Functional MRI, Other: Virtual reality / Memory assessment |
| Mild Cognitive Impairment patients | Experimental | Behavioral: Memory assessment, Other: Structural MRI, Other: Functional MRI, Other: Virtual reality / Memory assessment |
| Alzheimer Disease patients | Experimental | Behavioral: Memory assessment, Other: Structural MRI, Other: Functional MRI, Other: Virtual reality / Memory assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Education level > 7 years
- Native language: French
- Beck < 7
- Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:
Key exclusion criteria (10 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 (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 |
|---|---|---|
| Memory assessmentNeuropsychological tests including clinical and original tests to compare differences between each populations | Behavioural | Alzheimer Disease patients, Elderly Healthy Subjects, Middle age Healthy Subjects, Mild Cognitive Impairment patients, Young Healthy Subjects |
| Structural MRIto compare differences between each populations | Other | Alzheimer Disease patients, Elderly Healthy Subjects, Middle age Healthy Subjects, Mild Cognitive Impairment patients, Young Healthy Subjects |
| Functional MRIto compare differences between each populations | Other | Alzheimer Disease patients, Elderly Healthy Subjects, Middle age Healthy Subjects, Mild Cognitive Impairment patients, Young Healthy Subjects |
| Virtual reality / Memory assessmentto compare differences between each populations | Other | Alzheimer Disease patients, Elderly Healthy Subjects, Middle age Healthy Subjects, Mild Cognitive Impairment patients, Young Healthy Subjects |
Primary outcome
Rate of volume change of whole brain and other structural MRI measures
Time frame: 1 Month
Cerebral regions implicated in prospective memory observed by functional MRI
Time frame: 1 Month
Episodic memory as measured by Cognitive Tests
Time frame: 18 Months
Virtual reality evaluation of prospective memory
Time frame: 1 Month
Group differences for each imaging and neuropsychological measurement
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 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.
Vincent de La Sayette, MD principal investigator
University Hospital, Caen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory assessment, Structural MRI and Functional MRI in people with Alzheimer Disease, run by University Hospital, Caen at 3 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 9 inclusion and 10 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 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Contact Julien Chavant (+33231065495, memoire-recherche.caen@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of volume change of whole brain and other structural MRI measures (time frame: 1 Month). 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 9 Apr 2014.