Mild Cognitive ImpairmentADNI-GONCT01078636
Alzheimer's Disease Neuroimaging Initiative Grand Opportunity
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Alzheimer's Disease Cooperative Study (ADCS) at 55 sites in 2 countries.
Trial summary
The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- How many people
- 342 participants
- Where
- 55 sitesin 2 countries
- Study dates
- Apr 2010to Oct 2012
- Phase
- Observational
- 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 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
None listed.
Who cannot join
- Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
- Screening/baseline MRI scans with evidence of infection, infarction, or other focal lesions; multiple lacunes or lacunes in a critical memory structure
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
- Major depression, bipolar disorder as described in DSM-IV within the past 1 year
- Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol
- History of schizophrenia
Show all 15Show fewer
- History of alcohol or substance abuse or dependence within the past 2 years
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
- Clinically significant abnormalities in B12, or TFTs that might interfere with the study
- Residence in skilled nursing facility
- Current use of specific psychoactive medications (e.g.,certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); current use of warfarin (exclusionary for lumbar puncture)
- Use of investigational agents one month prior to entry and for the duration of the trial
- Participation in clinical studies involving neuropsychological measures being collected more than one time per year
- Exclusion for amyloid imaging with 18F -AV-45: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1
- Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the protocol director
Trial locations and contacts
55 sites in 2 countries.
55 sites in 2 countries
United States50 sites
Albany Medical College
Albany, New York, 12208
Dent Neurological Group
Amherst, New York, 14226
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30329
Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston University School of Medicine
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29406
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Case Western Reserve University
Cleveland, Ohio, 44122
Ohio State University
Columbus, Ohio, 43210
University of Texas SWMC
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of California, Irvine
Irvine, California, 92697
University of California, Irvine - BIC
Irvine, California, 92868
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224
University of Kansas
Kansas City, Kansas, 66160
Cleveland Clinic Lou Ruvo Center for Brain Health (CCLRBC)
Las Vegas, Nevada, 89106
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky
Lexington, Kentucky, 40536
University of Southern California
Los Angeles, California, 90033
University of California, Los Angeles
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53705
University of California, Davis
Martinez, California, 94553
Wien Center
Miami Beach, Florida, 33140
Yale University School of Medicine
New Haven, Connecticut, 06510
New York University
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
Columbia University
New York, New York, 10032
Stanford University
Palo Alto, California, 94304
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Butler Hospital Memory & Aging Program
Providence, Rhode Island, 02906
Mayo Clinic, Rochester
Rochester, Minnesota, 55901
University of Rochester Medical Center
Rochester, New York, 14620
University of California, San Diego
San Diego, California, 92037
University of California, San Francisco
San Francisco, California, 94143
Washington University, St. Louis
St Louis, Missouri, 63108
Banner Sun Health Research Institute
Sun City, Arizona, 85351
Georgetown University
Washington D.C., District of Columbia, 20057
Howard University
Washington D.C., District of Columbia, 20060
Premiere Research Institute
West Palm Beach, Florida, 33407
Wake Forest University
Winston-Salem, North Carolina, 27157
Canada5 sites
Saint Joseph's Hospital
Hamilton, Ontario, N6A 4V2
Parkwood Hospital
London, Ontario, N6C 5J1
Jewish General Hospital / McGill University
Montreal, Quebec, H3T 1E2
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University of British Columbia
Vancouver, British Columbia, V6T 2B5
About this study
The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI-GO seeks to define and characterize the mildest symptomatic phase of AD, referred to in this study as early amnestic MCI (EMCI). This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.
Read the detailed description
This project continues the work from ADNI1, the goal of which is to test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessments can be combined to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). The goal of the study is to determine relationships among the clinical, cognitive, imaging, genetic, and biochemical biomarker characteristics of the stage of the AD spectrum that precedes MCI, the mildest symptomatic phase of AD, referred to here as EMCI. The ADNI-GO model posits that AD begins with amyloid β (Aβ) deposition in the cortex, which leads to synaptic dysfunction, neurodegeneration, and cognitive/ functional decline.
Some of the leading-edge technologies under study are brain-imaging techniques, such as positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in the brain); PET using a radioactive compound (F-AV-45) that measures brain beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain's structure and function change as AD starts and progresses. Biomarkers in cerebrospinal fluid are revealing other changes that could identify which patients with MCI will develop Alzheimer's. Scientists are looking at levels of beta-amyloid and tau in cerebrospinal fluid. (Abnormal amounts of the amyloid and tau proteins in the brain are hallmarks of Alzheimer's disease.)
All participants from ADNI1 who are in the normal and MCI stages will continue to be followed in ADNI-GO. The next step is to scan and analyze the brains of people with EMCI; 200 EMCI participants will be enrolled to narrow the gap between cognitively normal (CN) and "late MCI (LMCI)" participants currently enrolled in ADNI.
The overall impact of this study will be increased knowledge concerning the sequence and timing of events leading to MCI and AD, development of better clinical and imaging/fluid biomarker methods for early detection and for monitoring the progression of these conditions, and facilitation of clinical trials of treatments to slow disease progression, ultimately contributing to the prevention of AD.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Keywords
- amyloid, plaques, imaging, early detection, Amnestic MCI, pre-dementia
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EMCI (only cohort recruiting in this study) | Newly recruited early amnestic Mild Cognitive Impairment patients; estimated enrollment 200 | |
| LMCI (not recruiting in this study) | Late Mild Cognitive Impairment patients; approximately 400 LMCI participants anticipated to follow from the original ADNI study | |
| CN (not recruiting in this study) | Cognitively Normal patients; approximately 200 CN participants anticipated to follow from the original ADNI study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Decline as measured by: Cognitive tests, Activities of Daily Living, and CDR Sum of Boxes
Measured: at screening, baseline, 6 (EMCI only) and 12 months
Secondary outcomes (8)
Rate of conversion will be evaluated among all four groups
Measured: at screening , baseline, 6 (EMCI only) and 12 months
Rate of volume change of whole brain, hippocampus, and other structural MRI measures
Measured: at screening and 3, 6, and 12 months (EMCI); at baseline and 12 months (follow-up patients)
Rates of change on each specified biochemical biomarker
Measured: at baseline, 6 (EMCI only) and 12 months
Rates of change of glucose metabolism (FDG-PET)
Measured: at baseline
Extent of amyloid deposition as measured by 18F-AV-45
Measured: at baseline
Group differences for each imaging and biomarker measurement
Measured: at screening, baseline, 6 (EMCI only) and 12 months
Correlations among biomarkers and biomarker change
Measured: at screening, baseline, 6 (EMCI only) and 12 months
Subgroups analyses: APOE genotype, low CSF Aβ42, positive amyloid imaging with 18F-AV-45
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alzheimer's Disease Cooperative Study (ADCS)
- Sponsor type
- University, hospital or other
- Collaborators
- Northern California Institute of Research and Education, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ronald Petersen, MD, PhD, Study chair, Mayo Clinic - Rochester, MinnesotaMichael W Weiner, MD, Principal investigator, University of California, San FranciscoPaul Aisen, MD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078636
- Sponsor's protocol ID
- IA0175
- Other IDs
- 1RC2AG036535-01
- Acronym
- ADNI-GO
- Status last verified
- Sep 2014
- First submitted
- 1 Mar 2010
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shen L, Kim S, Risacher SL, Nho K, Swaminathan S, West JD, Foroud T, Pankratz N, Moore JH, Sloan CD, Huentelman MJ, Craig DW, Dechairo BM, Potkin SG, Jack CR Jr, Weiner MW, Saykin AJ; Alzheimer's Disease Neuroimaging Initiative. Whole genome association study of brain-wide imaging phenotypes for identifying quantitative trait loci in MCI and AD: A study of the ADNI cohort. Neuroimage. 2010 Nov 15;53(3):1051-63. doi: 10.1016/j.neuroimage.2010.01.042. Epub 2010 Jan 25.
PubMed 20100581Risacher SL, Saykin AJ, West JD, Shen L, Firpi HA, McDonald BC; Alzheimer's Disease Neuroimaging Initiative (ADNI). Baseline MRI predictors of conversion from MCI to probable AD in the ADNI cohort. Curr Alzheimer Res. 2009 Aug;6(4):347-61. doi: 10.2174/156720509788929273.
PubMed 19689234Petersen RC, Aisen PS, Beckett LA, Donohue MC, Gamst AC, Harvey DJ, Jack CR Jr, Jagust WJ, Shaw LM, Toga AW, Trojanowski JQ, Weiner MW. Alzheimer's Disease Neuroimaging Initiative (ADNI): clinical characterization. Neurology. 2010 Jan 19;74(3):201-9. doi: 10.1212/WNL.0b013e3181cb3e25. Epub 2009 Dec 30.
PubMed 20042704Misra C, Fan Y, Davatzikos C. Baseline and longitudinal patterns of brain atrophy in MCI patients, and their use in prediction of short-term conversion to AD: results from ADNI. Neuroimage. 2009 Feb 15;44(4):1415-22. doi: 10.1016/j.neuroimage.2008.10.031. Epub 2008 Nov 5.
PubMed 19027862Miller AA, Sharp ES, Wang S, Zhao Y, Mecca AP, van Dyck CH, O'Dell RS; Alzheimer's Disease Neuroimaging Initiative (ADNI). Self-reported hearing loss is associated with faster cognitive and functional decline but not diagnostic conversion in the ADNI cohort. Alzheimers Dement. 2024 Nov;20(11):7847-7858. doi: 10.1002/alz.14252. Epub 2024 Sep 26.
PubMed 39324520Xu B, Ling Y, Liu L, Liu Y, Lin Y, Lyu J, Zhang Y. Potential prognostic value of CSF-targeted proteomics across the Alzheimer's disease continuum. BMC Geriatr. 2024 Jun 6;24(1):501. doi: 10.1186/s12877-024-05104-z.
PubMed 38844858
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease Neuroimaging Initiative Grand Opportunity
- ClinicalTrials.gov ID
- NCT01078636
- Acronym / sponsor ID
- ADNI-GO / IA0175
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Keywords
- amyloid, plaques, imaging, early detection, Amnestic MCI, pre-dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Alzheimer's Disease Cooperative Study (ADCS)University, hospital or other
- Collaborators
- Northern California Institute of Research and Education, National Institute on Aging (NIA)
- Study start
- Apr 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Mar 2010 (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 build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI-GO seeks to define and characterize the mildest symptomatic phase of AD, referred to in this study as early amnestic MCI (EMCI). This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.
Detailed description
This project continues the work from ADNI1, the goal of which is to test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessments can be combined to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). The goal of the study is to determine relationships among the clinical, cognitive, imaging, genetic, and biochemical biomarker characteristics of the stage of the AD spectrum that precedes MCI, the mildest symptomatic phase of AD, referred to here as EMCI. The ADNI-GO model posits that AD begins with amyloid β (Aβ) deposition in the cortex, which leads to synaptic dysfunction, neurodegeneration, and cognitive/ functional decline.
Some of the leading-edge technologies under study are brain-imaging techniques, such as positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in the brain); PET using a radioactive compound (F-AV-45) that measures brain beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain's structure and function change as AD starts and progresses. Biomarkers in cerebrospinal fluid are revealing other changes that could identify which patients with MCI will develop Alzheimer's. Scientists are looking at levels of beta-amyloid and tau in cerebrospinal fluid. (Abnormal amounts of the amyloid and tau proteins in the brain are hallmarks of Alzheimer's disease.)
All participants from ADNI1 who are in the normal and MCI stages will continue to be followed in ADNI-GO. The next step is to scan and analyze the brains of people with EMCI; 200 EMCI participants will be enrolled to narrow the gap between cognitively normal (CN) and "late MCI (LMCI)" participants currently enrolled in ADNI.
The overall impact of this study will be increased knowledge concerning the sequence and timing of events leading to MCI and AD, development of better clinical and imaging/fluid biomarker methods for early detection and for monitoring the progression of these conditions, and facilitation of clinical trials of treatments to slow disease progression, ultimately contributing to the prevention of AD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMCI (only cohort recruiting in this study) | – | –Newly recruited early amnestic Mild Cognitive Impairment patients; estimated enrollment 200 |
| LMCI (not recruiting in this study) | – | –Late Mild Cognitive Impairment patients; approximately 400 LMCI participants anticipated to follow from the original ADNI study |
| CN (not recruiting in this study) | – | –Cognitively Normal patients; approximately 200 CN participants anticipated to follow from the original ADNI study |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
- Screening/baseline MRI scans with evidence of infection, infarction, or other focal lesions; multiple lacunes or lacunes in a critical memory structure
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
- Major depression, bipolar disorder as described in DSM-IV within the past 1 year
- Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Decline as measured by: Cognitive tests, Activities of Daily Living, and CDR Sum of Boxes
Time frame: at screening, baseline, 6 (EMCI only) and 12 months
8 secondary outcomes
Rate of conversion will be evaluated among all four groups
Time frame: at screening , baseline, 6 (EMCI only) and 12 months
Rate of volume change of whole brain, hippocampus, and other structural MRI measures
Time frame: at screening and 3, 6, and 12 months (EMCI); at baseline and 12 months (follow-up patients)
Rates of change on each specified biochemical biomarker
Time frame: at baseline, 6 (EMCI only) and 12 months
Rates of change of glucose metabolism (FDG-PET)
Time frame: at baseline
Extent of amyloid deposition as measured by 18F-AV-45
Time frame: at baseline
Group differences for each imaging and biomarker measurement
Time frame: at screening, baseline, 6 (EMCI only) and 12 months
Correlations among biomarkers and biomarker change
Time frame: at screening, baseline, 6 (EMCI only) and 12 months
Subgroups analyses: APOE genotype, low CSF Aβ42, positive amyloid imaging with 18F-AV-45
Time frame: at baseline
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 16 Sep 2014.
- Background: PubMed 20100581Shen L, Kim S, Risacher SL, Nho K, Swaminathan S, West JD, Foroud T, Pankratz N, Moore JH, Sloan CD, Huentelman MJ, Craig DW, Dechairo BM, Potkin SG, Jack CR Jr, Weiner MW, Saykin AJ; Alzheimer's Disease Neuroimaging Initiative. Whole genome association study of brain-wide imaging phenotypes for identifying quantitative trait loci in MCI and AD: A study of the ADNI cohort. Neuroimage. 2010 Nov 15;53(3):1051-63. doi: 10.1016/j.neuroimage.2010.01.042. Epub 2010 Jan 25.
- Background: PubMed 19689234Risacher SL, Saykin AJ, West JD, Shen L, Firpi HA, McDonald BC; Alzheimer's Disease Neuroimaging Initiative (ADNI). Baseline MRI predictors of conversion from MCI to probable AD in the ADNI cohort. Curr Alzheimer Res. 2009 Aug;6(4):347-61. doi: 10.2174/156720509788929273.
- Background: PubMed 20042704Petersen RC, Aisen PS, Beckett LA, Donohue MC, Gamst AC, Harvey DJ, Jack CR Jr, Jagust WJ, Shaw LM, Toga AW, Trojanowski JQ, Weiner MW. Alzheimer's Disease Neuroimaging Initiative (ADNI): clinical characterization. Neurology. 2010 Jan 19;74(3):201-9. doi: 10.1212/WNL.0b013e3181cb3e25. Epub 2009 Dec 30.
- Background: PubMed 19027862Misra C, Fan Y, Davatzikos C. Baseline and longitudinal patterns of brain atrophy in MCI patients, and their use in prediction of short-term conversion to AD: results from ADNI. Neuroimage. 2009 Feb 15;44(4):1415-22. doi: 10.1016/j.neuroimage.2008.10.031. Epub 2008 Nov 5.
- Derived from this study: PubMed 39324520Miller AA, Sharp ES, Wang S, Zhao Y, Mecca AP, van Dyck CH, O'Dell RS; Alzheimer's Disease Neuroimaging Initiative (ADNI). Self-reported hearing loss is associated with faster cognitive and functional decline but not diagnostic conversion in the ADNI cohort. Alzheimers Dement. 2024 Nov;20(11):7847-7858. doi: 10.1002/alz.14252. Epub 2024 Sep 26.
- Derived from this study: PubMed 38844858Xu B, Ling Y, Liu L, Liu Y, Lin Y, Lyu J, Zhang Y. Potential prognostic value of CSF-targeted proteomics across the Alzheimer's disease continuum. BMC Geriatr. 2024 Jun 6;24(1):501. doi: 10.1186/s12877-024-05104-z.
- Laboratory of NeuroImaging: Alzheimer's Disease Neuroimaging InitiativeLink provided by the sponsor.
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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.
Ronald Petersen, MD, PhD study chair
Mayo Clinic - Rochester, Minnesota
Michael W Weiner, MD principal investigator
University of California, San Francisco
Paul Aisen, MD study chair
University of California, San Diego
55 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Alzheimer's Disease Cooperative Study (ADCS) at 55 sites in 2 countries.
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 0 inclusion and 15 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 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Canada. 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 Decline as measured by: Cognitive tests, Activities of Daily Living, and CDR Sum of Boxes (time frame: at screening, baseline, 6 (EMCI only) and 12 months). 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 NCT01078636, which also lists 6 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 16 Sep 2014.