Alzheimer's DiseaseIMPRONCT02522091
Cerebral Substrates of Prospective Memory in Young and Its Disruption in Normal Aging and in Alzheimer's Disease: A Study in Anatomical MRI, Diffusion Tensor MRI and Functional MRI
A study testing functional brain MRI and Neuropsychology tests in people with Alzheimer's Disease, run by University Hospital, Caen at 1 site in France.
Trial summary
Investigators propose in this study to evaluate prospective memory (MP) in all its complexity as well as the processes, cognitive and brain, the underlying. Specifically, investigators propose to evaluate the evolution of the MP during normal aging and Alzheimer's disease (AD) to identify the cognitive and brain… Read more about this study
- 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?
- functional brain MRI and Neuropsychology tests
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Dec 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
- All participants:
- Normal Education> 7 years
- French mother tongue
- right-handed (Edinburgh Inventory)
- score on the scale of Beck <7 (depression scale)
- signing the informed consent of the protocol in agreement with the Committee to Protect People
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- Medical examinations, neurological, neuropsychological and neuroimaging depth in accordance with the specific inclusion and exclusion criteria for each population, that is to say:
- Young healthy subjects aged between 18 and 44 years
- Healthy subjects intermediate age: between 45 and 69 years
- score on the Mattis Dementia Scale higher than 137, in order to exclude any potential dementia
- Performance "normal" to test RI RL-16 (that is to say, not differing by more than 1.65 standard deviation from the norm for age and cultural level [see normative values published Van der Linden et al., 2004]), test conventionally used to assess the verbal episodic memory.
- Healthy elderly subjects aged 70 and over, living at home
- score on the Mattis Dementia Scale higher than 137, in order to exclude any potential dementia
- Performance "normal" to test RI RL-16 (that is to say, not differing by more than 1.65 standard deviation from the norm for age and cultural level [see normative values published Van der Linden et al., 2004]), test conventionally used to assess the verbal episodic memory.
- MCI patients: older than 50 years and recruited from memory clinics and meet the current criteria and recognized including amnestic MCI
- memory complaint
- targets deficits of episodic memory (lower performance of at least 1 standard deviation from the norm for age and cultural level to one or more (sub) episodic memory scores of diagnostic battery - cf. . Tables 1 and infra)
- performance in the standards for age and cultural level in all tests of diagnostic battery measuring other cognitive functions as memory, including the evaluation of overall cognitive ability tests.
- Alzheimer's patients: older than 50 years were recruited from the clinics and memory satisfying the standards NINCDS-ADRDA criteria for probable AD which include
- abnormal global cognitive functioning and deficits in two or more cognitive domains identified by the diagnostic battery
- mild to moderate AD (MMSE ≥ 18).
Who cannot join
- Cognitive disorders of sudden onset (contrary to their slow and progressive onset in AD), which could reflect a stroke; a modified Hachinski ischemic score ≤ 2 (Loeb \& Gandolfo, 1983); history of head trauma with loss of consciousness for more than 1 hour, or encephalitis;
- Chronic neurological disease, psychiatric, endocrine, hepatic, infectious;
- A history of major illness (chronic lung disease, heart disorder, metabolic, hematologic, endocrine or immunological severe, cancer);
- A medication that may interfere with the mnemonic or metabolic measures (psychotropics, hypnotics, anxiolytics, neuroleptics, anti-Parkinson, benzodiazepines, anti-inflammatory drugs, antiepileptics, antihistamines, analgesics and muscle relaxants central, as is usual The investigating doctor deems the annoying character for the study of the regular intake of certain medications). Taking anticholinesterase treatment will also be a criterion for non-inclusion.
- Chronic intake of alcohol or drugs;
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de neurologie
Caen, CHU, 14000
Vincent de la Sayette, MD, PhD, 02.31.06.46.24
About this study
Investigators propose in this study to evaluate prospective memory (MP) in all its complexity as well as the processes, cognitive and brain, the underlying. Specifically, investigators propose to evaluate the evolution of the MP during normal aging and Alzheimer's disease (AD) to identify the cognitive and brain processes underlying this development. To do this, this study will have to include healthy subjects, 18 to 95 years, patients with Mild Cognitive Impairment (MCI) and patients with probable AD. All participants will undergo a series of examinations, both neuropsychological and brain imaging.
- Conditions
- Alzheimer's Disease
- Being tested
- functional brain MRI, Neuropsychology tests
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional brain MRIDevice
Neuropsychology testsOther
| Study group | Role | What they receive |
|---|---|---|
| young healthy volunteers (18-44 years old) | Other | young healthy volunteers (18-44 years old) Receives: Device: functional brain MRI; Other: Neuropsychology tests |
| healthy volunteers (45-69 years old) | Other | healthy volunteers (45-69 years old) Receives: Device: functional brain MRI; Other: Neuropsychology tests |
| Mild Cognitive Impairment Patients | Other | Mild Cognitive Impairment Patients Receives: Device: functional brain MRI; Other: Neuropsychology tests |
| Alzheimer's Disease patient | Other | Alzheimer's Disease patient Receives: Device: functional brain MRI; Other: Neuropsychology tests |
| old healthy volunteers (70+ years old) | Other | old healthy volunteers (70+ years old) Receives: Device: functional brain MRI; Other: Neuropsychology tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring the amplitude of the BOLD signal (Blood Oxygen Level Dependent)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startNov 2010
- Primary completionDec 2015 (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 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522091
- Sponsor's protocol ID
- 10-002
- Acronym
- IMPRO
- Status last verified
- Aug 2015
- First submitted
- 5 Aug 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Substrates of Prospective Memory in Young and Its Disruption in Normal Aging and in Alzheimer's Disease: A Study in Anatomical MRI, Diffusion Tensor MRI and Functional MRI
- ClinicalTrials.gov ID
- NCT02522091
- Acronym / sponsor ID
- IMPRO / 10-002
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2015 (estimated)
- First posted
- 13 Aug 2015 (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.
Investigators propose in this study to evaluate prospective memory (MP) in all its complexity as well as the processes, cognitive and brain, the underlying. Specifically, investigators propose to evaluate the evolution of the MP during normal aging and Alzheimer's disease (AD) to identify the cognitive and brain processes underlying this development. To do this, this study will have to include healthy subjects, 18 to 95 years, patients with Mild Cognitive Impairment (MCI) and patients with probable AD. All participants will undergo a series of examinations, both neuropsychological and brain imaging.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| young healthy volunteers (18-44 years old) | Other | Device: functional brain MRI, Other: Neuropsychology testsyoung healthy volunteers (18-44 years old) |
| healthy volunteers (45-69 years old) | Other | Device: functional brain MRI, Other: Neuropsychology testshealthy volunteers (45-69 years old) |
| Mild Cognitive Impairment Patients | Other | Device: functional brain MRI, Other: Neuropsychology testsMild Cognitive Impairment Patients |
| Alzheimer's Disease patient | Other | Device: functional brain MRI, Other: Neuropsychology testsAlzheimer's Disease patient |
| old healthy volunteers (70+ years old) | Other | Device: functional brain MRI, Other: Neuropsychology testsold healthy volunteers (70+ years old) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- All participants:
- Young healthy subjects aged between 18 and 44 years
- Healthy subjects intermediate age: between 45 and 69 years
- Healthy elderly subjects aged 70 and over, living at home
- MCI patients: older than 50 years and recruited from memory clinics and meet the current criteria and recognized including amnestic MCI
Key exclusion criteria (5 listed)
- Cognitive disorders of sudden onset (contrary to their slow and progressive onset in AD), which could reflect a stroke; a modified Hachinski ischemic score ≤ 2 (Loeb \& Gandolfo, 1983); history of head trauma with loss of consciousness for more than 1 hour, or encephalitis;
- Chronic neurological disease, psychiatric, endocrine, hepatic, infectious;
- A history of major illness (chronic lung disease, heart disorder, metabolic, hematologic, endocrine or immunological severe, cancer);
- A medication that may interfere with the mnemonic or metabolic measures (psychotropics, hypnotics, anxiolytics, neuroleptics, anti-Parkinson, benzodiazepines, anti-inflammatory drugs, antiepileptics, antihistamines, analgesics and muscle relaxants central, as is usual The investigating doctor deems the annoying character for the study of the regular intake of certain medications). Taking anticholinesterase treatment will also be a criterion for non-inclusion.
- Chronic intake of alcohol or drugs;
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 |
|---|---|---|
| functional brain MRI | Device | Alzheimer's Disease patient, Mild Cognitive Impairment Patients, healthy volunteers (45-69 years old), old healthy volunteers (70+ years old), young healthy volunteers (18-44 years old) |
| Neuropsychology tests | Other | Alzheimer's Disease patient, Mild Cognitive Impairment Patients, healthy volunteers (45-69 years old), old healthy volunteers (70+ years old), young healthy volunteers (18-44 years old) |
Primary outcome
measuring the amplitude of the BOLD signal (Blood Oxygen Level Dependent)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional brain MRI and Neuropsychology tests in people with Alzheimer's Disease, run by University Hospital, Caen 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 21 inclusion and 5 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 13 Aug 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring the amplitude of the BOLD signal (Blood Oxygen Level Dependent) (time frame: baseline). 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 13 Aug 2015.