Alzheimer's DiseaseIMAP+NCT01638949
Multi-modal Neuroimaging in Alzheimer's Disease IMAP+
A study testing Memory assessment, Circulating biomarkers measure and ApoE4 in people with Alzheimer's Disease, run by University Hospital, Caen at 7 sites in France.
Trial summary
Alzheimer's disease (AD) is a major public health problem due to its socio-economic weight. An early diagnosis of AD is urgently needed as it would constitute a determinant breakthrough from a social, financial and research standpoints. 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?
- Memory assessment, Circulating biomarkers measure and ApoE4
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 7 sitesFrance
- Study dates
- May 2012to 20 Sep 2022
- 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 volunteers: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.65 SD).
- Healthy Middle-aged volunteers: 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 (± 1.65 SD).
- Healthy Elderly volunteers: 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 (± 1.65 SD).
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- SCI patients: over 60 years old ; memory complaints; memory complaint ; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.65 SD).
- MCI patients: presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.65 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
- The cons-indications to MRI (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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
GIP Cyceron
Caen, Calvados, 14000
Inserm - EPHE - University of Caen U1077
Caen, 14000
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
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
Alzheimer's disease (AD) is a major public health problem due to its socio-economic weight. An early diagnosis of AD is urgently needed as it would constitute a determinant breakthrough from a social, financial and research standpoints. Therefore, the investigators need predictive markers of AD, and neuroimaging is a particularly promising tool, especially when using complementary neuroimaging techniques and a longitudinal design, allowing to assess the relationships between the different biomarkers of the disease, their dynamic and their chronology.
Read the detailed description
The three main objectives of this project are:
- To Identify, compare and combine the predictive markers of AD,
- To better understand the pathophysiologic mechanisms of AD,
- To study the ability of different neuroimaging techniques to monitor AD's evolution.
For these purposes, detailed neuropsychological evaluations, biological measures and brain structural \& functional imaging measures are associated for a fully-comprehensive description of the different manifestations of AD through disease progression and toward identifying early markers.
Subjects are evaluated using neuropsychological tests of episodic memory (encoding vs. retrieval), executive functions (inhibition, flexibility, and updating processes), self-judgment, theory of mind, mental imagery and verbal fluency. A FDG-PET measure of resting state glucose consumption, an AV45-PET measure of amyloid deposition as well as anatomical, resting-state and activation fMRI scans are performed for each volonteer. In addition, blood and cerebro-spinal fluid samples will be performed to determine different biomarkers (Aβ1-40, Aβ1-42 and tPA as circulating blood proteins and Aβ40, Aβ42, tau and its phosphorylated form in CSF). The investigators also study the polymorphism of Apolipoprotein E as a genetic risk factor of AD.
One hundred and twenty healthy controls (40 young, 40 middle age and 40 elderly), 40 Mild Cognitive Impairment patients (MCI; i.e. isolated memory impairment and increased risk of developing AD) and 30 AD patients will be selected. Participants with increased risk of developing AD and without objective evidence will be also studied: 50 asymptomatic subjects from families carrying a genetic mutation with an autosomal dominant transmission (NORMA) and 40 Subjective Cognitive Impairment patients (SCI).
Clinical follow-up of patients will be completed during 36 months (18 months for AD patients), as a neuropsychological evaluation every 6 months. Comparable neuropsychological and imaging exams will be proposed once again after 18 months for all participants as well as after 36 months for elderly controls, NORMA and SCI \& MCI patients.
To study and compare the effectiveness of different in vivo markers (to predict cognitive decline in populations at risk of developing AD), each data set (i.e. modality) will be first analyzed independently from one another (intra-modality analyses), including inter-group comparisons, correlations and connectivity analyses, as well as longitudinal assessment of cognitive, biological and brain changes. Baseline data will also be analyzed in function of patient's clinical evolution to assess their predictive value. Comparisons and correlations between the different patterns of alterations will then be performed through inter-modality analyses. More specifically, the investigators will address the questions of the relationships between cognitive and cerebral alterations and structural / functional brain changes over our different patient samples, neuroimaging data sets, and through disease evolution.
This project is expected to identify specific and early markers of the MA and also to compare the diagnostic efficiency of different measures. It should contribute to better understand brain and cognitive alterations in AD. Finally, the investigators will be able to appreciate the dynamic properties of these alterations in the evolution of the disease through the longitudinal study.
- Conditions
- Alzheimer's Disease
- Being tested
- Memory assessment, Circulating biomarkers measure, 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.
Memory assessmentBehavioural
Neuropsycological tests including clinical and original tests to compare differences between each populations.
Circulating biomarkers measureBiological
ELISA tests from blood samples to compare differences between each populations.
ApoE4Genetic
Evaluation of apolipoprotein E polymorphism as a risk factor.
Brain imaging examination MRI and PET examinationsOther
Structural and functional MRI FDG-PET to compare differences between each populations.
| Study group | Role | What they receive |
|---|---|---|
| Young controls | Experimental | Not described Receives: Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations |
| Middle age controls | Experimental | Not described Receives: Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations |
| Elderly controls | Experimental | Not described Receives: Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations |
| Asymptomatic subjects | Experimental | Asymptomatic subjects from families carrying a genetic mutation with an autosomal dominant transmission Receives: Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations |
| Subjectif Cognitive Impariment patients | Experimental | Not described Receives: Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations |
| Mild Cognitive Impairment patients | Experimental | Not described Receives: Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations |
| Alzheimer Disease patients | Experimental | Not described Receives: Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations |
| Non degenerative amnsesic syndrome | Experimental | Not described Receives: Behavioral: Memory assessment; Biological: Circulating biomarkers measure; 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.
- First posted12 Jul 2012 (estimated)
- Study startMay 2012
- Primary completion20 Jan 2020
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Factorial
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
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
- NCT01638949
- Sponsor's protocol ID
- 2011-A01493-38
- Acronym
- IMAP+
- Status last verified
- Apr 2014
- First submitted
- 22 May 2012
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kuhn E, Perrotin A, La Joie R, Touron E, Dautricourt S, Vanhoutte M, Vivien D, de La Sayette V, Chetelat G; Alzheimer's Disease Neuroimaging Initiative. Association of the Informant-Reported Memory Decline With Cognitive and Brain Deterioration Through the Alzheimer Clinical Continuum. Neurology. 2023 Jun 13;100(24):e2454-e2465. doi: 10.1212/WNL.0000000000207338. Epub 2023 Apr 21.
PubMed 37085328Kuhn E, Moulinet I, Perrotin A, La Joie R, Landeau B, Tomadesso C, Bejanin A, Sherif S, De La Sayette V, Desgranges B, Vivien D, Poisnel G, Chetelat G. Cross-sectional and longitudinal characterization of SCD patients recruited from the community versus from a memory clinic: subjective cognitive decline, psychoaffective factors, cognitive performances, and atrophy progression over time. Alzheimers Res Ther. 2019 Jul 8;11(1):61. doi: 10.1186/s13195-019-0514-z.
PubMed 31286994Gonneaud J, Arenaza-Urquijo EM, Fouquet M, Perrotin A, Fradin S, de La Sayette V, Eustache F, Chetelat G. Relative effect of APOE epsilon4 on neuroimaging biomarker changes across the lifespan. Neurology. 2016 Oct 18;87(16):1696-1703. doi: 10.1212/WNL.0000000000003234. Epub 2016 Sep 28.
PubMed 27683850
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. 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
- NCT01638949
- Acronym / sponsor ID
- IMAP+ / 2011-A01493-38
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, MCI, genetic, AV45-PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- May 2012 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Sep 2022 (actual)
- 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.
Alzheimer's disease (AD) is a major public health problem due to its socio-economic weight. An early diagnosis of AD is urgently needed as it would constitute a determinant breakthrough from a social, financial and research standpoints. Therefore, the investigators need predictive markers of AD, and neuroimaging is a particularly promising tool, especially when using complementary neuroimaging techniques and a longitudinal design, allowing to assess the relationships between the different biomarkers of the disease, their dynamic and their chronology.
Detailed description
The three main objectives of this project are:
- To Identify, compare and combine the predictive markers of AD,
- To better understand the pathophysiologic mechanisms of AD,
- To study the ability of different neuroimaging techniques to monitor AD's evolution.
For these purposes, detailed neuropsychological evaluations, biological measures and brain structural \& functional imaging measures are associated for a fully-comprehensive description of the different manifestations of AD through disease progression and toward identifying early markers.
Subjects are evaluated using neuropsychological tests of episodic memory (encoding vs. retrieval), executive functions (inhibition, flexibility, and updating processes), self-judgment, theory of mind, mental imagery and verbal fluency. A FDG-PET measure of resting state glucose consumption, an AV45-PET measure of amyloid deposition as well as anatomical, resting-state and activation fMRI scans are performed for each volonteer. In addition, blood and cerebro-spinal fluid samples will be performed to determine different biomarkers (Aβ1-40, Aβ1-42 and tPA as circulating blood proteins and Aβ40, Aβ42, tau and its phosphorylated form in CSF). The investigators also study the polymorphism of Apolipoprotein E as a genetic risk factor of AD.
One hundred and twenty healthy controls (40 young, 40 middle age and 40 elderly), 40 Mild Cognitive Impairment patients (MCI; i.e. isolated memory impairment and increased risk of developing AD) and 30 AD patients will be selected. Participants with increased risk of developing AD and without objective evidence will be also studied: 50 asymptomatic subjects from families carrying a genetic mutation with an autosomal dominant transmission (NORMA) and 40 Subjective Cognitive Impairment patients (SCI).
Clinical follow-up of patients will be completed during 36 months (18 months for AD patients), as a neuropsychological evaluation every 6 months. Comparable neuropsychological and imaging exams will be proposed once again after 18 months for all participants as well as after 36 months for elderly controls, NORMA and SCI \& MCI patients.
To study and compare the effectiveness of different in vivo markers (to predict cognitive decline in populations at risk of developing AD), each data set (i.e. modality) will be first analyzed independently from one another (intra-modality analyses), including inter-group comparisons, correlations and connectivity analyses, as well as longitudinal assessment of cognitive, biological and brain changes. Baseline data will also be analyzed in function of patient's clinical evolution to assess their predictive value. Comparisons and correlations between the different patterns of alterations will then be performed through inter-modality analyses. More specifically, the investigators will address the questions of the relationships between cognitive and cerebral alterations and structural / functional brain changes over our different patient samples, neuroimaging data sets, and through disease evolution.
This project is expected to identify specific and early markers of the MA and also to compare the diagnostic efficiency of different measures. It should contribute to better understand brain and cognitive alterations in AD. Finally, the investigators will be able to appreciate the dynamic properties of these alterations in the evolution of the disease through the longitudinal study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Young controls | Experimental | Behavioral: Memory assessment, Biological: Circulating biomarkers measure, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinations |
| Middle age controls | Experimental | Behavioral: Memory assessment, Biological: Circulating biomarkers measure, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinations |
| Elderly controls | Experimental | Behavioral: Memory assessment, Biological: Circulating biomarkers measure, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinations |
| Asymptomatic subjects | Experimental | Behavioral: Memory assessment, Biological: Circulating biomarkers measure, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinationsAsymptomatic subjects from families carrying a genetic mutation with an autosomal dominant transmission |
| Subjectif Cognitive Impariment patients | Experimental | Behavioral: Memory assessment, Biological: Circulating biomarkers measure, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinations |
| Mild Cognitive Impairment patients | Experimental | Behavioral: Memory assessment, Biological: Circulating biomarkers measure, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinations |
| Alzheimer Disease patients | Experimental | Behavioral: Memory assessment, Biological: Circulating biomarkers measure, Genetic: ApoE4, Other: Brain imaging examination MRI and PET examinations |
| Non degenerative amnsesic syndrome | Experimental | Behavioral: Memory assessment, Biological: Circulating biomarkers measure, Genetic: ApoE4, Other: 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 (9 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 |
|---|---|---|
| Memory assessmentNeuropsycological tests including clinical and original tests to compare differences between each populations. | Behavioural | Alzheimer Disease patients, Asymptomatic subjects, Elderly controls, Middle age controls, Mild Cognitive Impairment patients, Non degenerative amnsesic syndrome, Subjectif Cognitive Impariment patients, Young controls |
| Circulating biomarkers measureELISA tests from blood samples to compare differences between each populations. | Biological | Alzheimer Disease patients, Asymptomatic subjects, Elderly controls, Middle age controls, Mild Cognitive Impairment patients, Non degenerative amnsesic syndrome, Subjectif Cognitive Impariment patients, Young controls |
| ApoE4Evaluation of apolipoprotein E polymorphism as a risk factor. | Genetic | Alzheimer Disease patients, Asymptomatic subjects, Elderly controls, Middle age controls, Mild Cognitive Impairment patients, Non degenerative amnsesic syndrome, Subjectif Cognitive Impariment patients, Young controls |
| Brain imaging examination MRI and PET examinationsStructural and functional MRI FDG-PET to compare differences between each populations. | Other | Alzheimer Disease patients, Asymptomatic subjects, Elderly controls, 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
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 2 Apr 2026.
- Results publication: PubMed 37085328Kuhn E, Perrotin A, La Joie R, Touron E, Dautricourt S, Vanhoutte M, Vivien D, de La Sayette V, Chetelat G; Alzheimer's Disease Neuroimaging Initiative. Association of the Informant-Reported Memory Decline With Cognitive and Brain Deterioration Through the Alzheimer Clinical Continuum. Neurology. 2023 Jun 13;100(24):e2454-e2465. doi: 10.1212/WNL.0000000000207338. Epub 2023 Apr 21.
- Derived from this study: PubMed 31286994Kuhn E, Moulinet I, Perrotin A, La Joie R, Landeau B, Tomadesso C, Bejanin A, Sherif S, De La Sayette V, Desgranges B, Vivien D, Poisnel G, Chetelat G. Cross-sectional and longitudinal characterization of SCD patients recruited from the community versus from a memory clinic: subjective cognitive decline, psychoaffective factors, cognitive performances, and atrophy progression over time. Alzheimers Res Ther. 2019 Jul 8;11(1):61. doi: 10.1186/s13195-019-0514-z.
- Derived from this study: PubMed 27683850Gonneaud J, Arenaza-Urquijo EM, Fouquet M, Perrotin A, Fradin S, de La Sayette V, Eustache F, Chetelat G. Relative effect of APOE epsilon4 on neuroimaging biomarker changes across the lifespan. Neurology. 2016 Oct 18;87(16):1696-1703. doi: 10.1212/WNL.0000000000003234. Epub 2016 Sep 28.
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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
7 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, Circulating biomarkers measure and ApoE4 in people with Alzheimer's Disease, run by University Hospital, Caen at 7 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 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: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
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 NCT01638949, which also lists 3 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 2 Apr 2026.