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Mild Cognitive Impairment (MCI)ADNI2NCT01231971

Alzheimer's Disease Neuroimaging Initiative 2

An observational study of Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD), run by University of Southern California at 58 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how brain imaging technology can be used with other… Read more about this study

Who is it for?
Ages 55 to 90 yearsHealthy volunteers can take part
What is being tested?
Florbetapir and Flortaucipir
Type of treatment
Injection or infusion
How many people
1,182 participants
Where
58 sitesin 2 countries
Study dates
14 Feb 2011to 29 Nov 2017
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

  • Participants will be classified as either normal controls, SMC, EMCI, LMCI or AD participants. General Inclusion Criteria will apply to all groups, with specific criteria for each group as described below:
  • General (applies to each category):
  • Geriatric Depression Scale less than 6.
  • Age between *55-90 (inclusive). *For normal controls and SMC participants, age must be between 65-90.
  • Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol.
  • Visual and auditory acuity adequate for neuropsychological testing.
Show all 67Show fewer
  • Good general health with no diseases expected to interfere with the study.
  • Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
  • Willing and able to participate in a longitudinal imaging study.
  • Hachinski less than or equal to 4.
  • Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
  • Must speak English or Spanish fluently.
  • Willing to undergo repeated MRIs (3Tesla) and at least two PET scans (one FDG and one Amyloid imaging) and no medical contraindications to MRI.
  • Agrees to collection of blood for Genome Wide Association Studies (GWAS), APOE testing and DNA and RNA banking.
  • Agrees to collection of blood for biomarker testing.
  • Agrees to at least one lumbar puncture for the collection of CSF.
  • Specific Inclusion Criteria for normal controls:
  • Participant must be free of memory complaints, verified by a study partner.
  • Normal memory function score on Wechsler Memory Scale (adjusted for education)
  • Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
  • Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0
  • Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
  • Stability of Permitted Medications for 4 weeks. In particular, participants may take:
  • Antidepressants lacking significant anticholinergic side effects
  • Estrogen replacement therapy is permissible
  • Gingko biloba is permissible, but discouraged
  • Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
  • Specific Inclusion Criteria for SMC participants:
  • Subjects that are "self-referrals" that have a significant subjective memory concern
  • Significant memory concern confirmed by a Cognitive Change Index score of more than or equal to 16
  • Normal memory function score on Wechsler Memory Scale (adjusted for education)
  • Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
  • Clinical Dementia Rating (CDR) = 0; Memory Box score must be 0
  • Cognitively normal, based on the absence of significant memory impairment in cognitive function or activities of daily living
  • Stability of Permitted Medications for 4 weeks. In particular, subjects may take:
  • Antidepressants lacking significant anticholinergic side effects
  • Estrogen replacement therapy is permissible
  • Gingko biloba is permissible, but discouraged
  • Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
  • Specific Inclusion Criteria for EMCI and LMCI participants:
  • Participant must have a subjective memory concern as reported by participant, study partner, or clinician
  • Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
  • Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive)
  • Clinical Dementia Rating (CDR) = 0.5; Memory Box score must be at least 0.5
  • General cognition and functional performance sufficiently preserved such that a diagnosis of AD cannot be made by the site physician at the time of the screening visit
  • Stability of Permitted Medications for 4 weeks. In particular, participants may take:
  • Antidepressants lacking significant anticholinergic side effects
  • Estrogen replacement therapy
  • Gingko biloba is permissible, but discouraged
  • Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
  • Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening
  • Specific Inclusion Criteria for AD participants:
  • Participant must have a subjective memory concern as reported by participant, study partner, or clinician
  • Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
  • Mini-Mental State Exam (MMSE) score between 20 and 26 (inclusive)
  • Clinical Dementia Rating (CDR) = 0.5 or 1.0
  • National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
  • Stability of Permitted Medications for 4 weeks. In particular, participants may take:
  • Antidepressants lacking significant anticholinergic side effects
  • Estrogen replacement therapy
  • Gingko biloba is permissible, but discouraged
  • Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
  • Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screening
  • Specific Inclusion Criteria for follow-up participants from ADNI1 and ADNI GO:
  • Must have been enrolled and followed in ADNI1 for at least one year or enrolled in ADNI-GO with original diagnosis of Cognitively Normal (CN), Mild Cognitive Impairment (MCI), or Early Mild Cognitive Impairment (EMCI) regardless of whether a diagnostic conversion has occurred since initial enrollment in ADNI.
  • Willing and able to continue to participate in an ongoing longitudinal study. A reduced battery of tests is allowable if the participant is not able/willing to complete the full battery.
  • Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol.

Who cannot join

  • General (applies to each category):
  • Screening/baseline MRI scan with evidence of infection, infarction, or other focal lesions; Participants with multiple lacunes or lacunes in a critical memory structure are excluded
  • 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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) within the past 1 year
  • Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder
  • History of schizophrenia
Show all 23Show 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 or dabigatran (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 FDG PET scan and amyloid imaging with Florbetapir F 18: 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
  • Specific Exclusion Criteria for normal controls and SMC participants:
  • Any significant neurologic 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
  • Specific Exclusion Criteria for EMCI and LMCI participants:
  • 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.
  • Specific Exclusion Criteria for AD participants:
  • Any significant neurologic disease other than 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.
  • Specific Exclusion Criteria for follow-up participants from ADNI1 and ADNI GO:
  • Participants will not be able to participate in FDG PET scan and amyloid imaging with Florbetapir F 18 if the following is true: 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.

Trial locations and contacts

58 sites in 2 countries.

58 sites in 2 countries

United States53 sites

  • Albany Medical College

    Albany, New York, 12208

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30329

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Case Western Reserve University

    Beachwood, Ohio, 44122

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston University

    Boston, Massachusetts, 02118

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    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 Iowa

    Iowa City, Iowa, 52242

  • University of California, Irvine

    Irvine, California, 92697

  • Mayo Clinic, Jacksonville

    Jacksonville, Florida, 32224

  • University of Kansas

    Kansas City, Kansas, 66160

  • University of California, San Diego

    La Jolla, California, 92037

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • Dartmouth 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 for Clinical Research

    Miami Beach, Florida, 33140

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • New York University Medical Center

    New York, New York, 10016

  • Columbia University

    New York, New York, 10032

  • Mount Sinai School of Medicine

    New York, New York, 10032

  • Roper St. Francis Healthcare

    North Charleston, South Carolina, 29406

  • University of California, Irvine (Brain Imaging Center)

    Orange, California, 92868

  • Nathan S. Kline Institute for Psychiatric Research

    Orangeburg, New York, 10962

  • Stanford University / PAIRE

    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 and 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 Francisco

    San Francisco, California, 94158

  • Washington University, St. Louis

    St Louis, Missouri, 63108

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • USF Health Byrd Alzheimer's Institute

    Tampa, Florida, 33613

  • 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 Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada5 sites

  • Parkwood Institute

    London, Ontario, N6C 5J1

  • St. Joseph's Health Center - Cognitive Neurology

    London, Ontario, N6C 5J1

  • McGill University / Jewish General Hospital Memory Clinic

    Montreal, Quebec, H3T 1E2

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University of British Columbia, Clinic for Alzheimer's Disease and Related Disorders Program

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

About this study

The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Recovery and Reinvestment Act), 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). ADNI2 seeks to inform the neuroscience of AD. 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

The Alzheimer's Disease Neuroimaging Initiative (ADNI) began in October 2004 as a landmark study with a public-private partnership that gathered and analyzed thousands of brain scans, genetic profiles and biomarkers in blood and cerebrospinal fluid (CSF). Although the original goal was to define biomarkers for use in clinical trials to determine the best way to measure treatment effects of Alzheimer's disease (AD), the goal has been expanded to using biomarkers to identify AD at a pre-dementia stage. ADNI1 involves scientists at 59 research centers, 54 in the U.S. and five in Canada. Originally 800 participants were enrolled. This group was comprised of 200 participants with AD, 400 with mild cognitive impairment (MCI) and 200 with normal cognition. In ADNI-GO, an estimated 200 participants with early amnestic MCI (EMCI) were enrolled to understand and characterize the mildest symptomatic phase of AD. An additional 650 participants will be enrolled under ADNI2.

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 (Florbetapir F 18) 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.)

ADNI2 extends the work of ADNI1 and ADNI GO to understand the progression of AD. The overall goal is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD, as the pathology evolves from normal aging through very mild symptoms, to MCI, to dementia.

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 to slow disease progression, ultimately contributing to the prevention of AD.

Being tested
Florbetapir, Flortaucipir
Keywords
amyloid, plaques, neuroimaging, biomarkers, cognition disorder, early detection, Amnestic MCI, pre-dementia, dementia, Alzheimer's disease, tau
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease, Plaque, Amyloid, Cognition Disorders, Dementia, Pick Disease of the Brain

What participants receive

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

  • FlorbetapirDrug

    Also called 18F-AV-45, LY3078786

    Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) (+/- 10%) florbetapir F18. At approximately 50-minutes post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.

  • FlortaucipirDrug

    Also called 18F-AV-1451 (also known as [F-18]T807 or LY3191748)

    Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) flortaucipir injection followed by a saline flush. At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.

Study groups in NCT01231971
Study groupRoleWhat they receive
Cognitively Normal (CN)150 newly enrolled participants with no apparent memory problems, and CN participants followed from the ADNI1 study
Receives: Drug: Florbetapir; Drug: Flortaucipir
Early Mild Cognitive Impairment (EMCI)100 newly enrolled early amnestic MCI participants, and approximately 200 EMCI participants will be followed from the ADNI-GO study
Receives: Drug: Florbetapir; Drug: Flortaucipir
Late Mild Cognitive Impairment (LMCI)150 newly enrolled late MCI participants, and LMCI participants followed from the ADNI1 study
Receives: Drug: Florbetapir; Drug: Flortaucipir
Alzheimer's Disease (AD)150 newly enrolled mild AD participants
Receives: Drug: Florbetapir; Drug: Flortaucipir
Significant Memory Concern (SMC)100 newly enrolled participants with Significant Memory Concern (SMC)
Receives: Drug: Florbetapir; Drug: Flortaucipir

What is being measured

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

  1. Rate of volume change of whole brain, hippocampus and other structural MRI measures

    Measured: 5 Years

Secondary outcomes (10)

  1. Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes

    Measured: 5 Years

  2. Rate of conversion will be evaluated among all five groups

    Measured: 5 Years

  3. Rates of change on each specified biochemical biomarker

    Measured: 5 Years

  4. Rates of change of glucose metabolism (FDG-PET)

    Measured: 5 Years

  5. Extent of amyloid deposition as measured by Florbetapir F 18

    Measured: 4 Years

  6. Group differences for each imaging and biomarker measurement

    Measured: 5 Years

  7. Correlations among biomarkers and biomarker change

    Measured: 4 Years

  8. APOE genotype, low CSF Aβ42, positive amyloid imaging with florbetapir F 18 (AV-45)

    Measured: 5 Years

  9. Rate of change of tau and extent of tau deposition as measured by flortaucipir (18F-AV-1451)

    Measured: 1 Year

  10. Rate of cognitive decline using computer based testing as measured by Cogstate Brief Battery (CBB)

    Measured: 1 year

Timeline

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

  1. First posted1 Nov 2010 (estimated)
  2. Study start14 Feb 2011
  3. Primary completion29 Nov 2017
  4. Study completion29 Nov 2017

Resources

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
Cohort
Time perspective
Prospective
Enrolment
1,182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01231971
Sponsor's protocol ID
ADC-039-ADNI2
Other IDs
U01AG024904
Acronym
ADNI2
Status last verified
Nov 2024
First submitted
27 Oct 2010
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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 20100581

  • Risacher 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 19689234

  • Petersen 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 20042704

  • Misra 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 19027862

  • Howe MD, Zide BS, Hayes K, Ross D, Barker MS, Kunicki ZJ, Rudolph J, Huey E. Symptom-Guided Blood Biomarker Testing for Alzheimer's Disease. Dement Geriatr Cogn Disord. 2026 Oct 12:1. doi: 10.1159/dem/aciag010. Online ahead of print.

    PubMed 42862762

  • Miller 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 39324520

  • Howe MD, Caruso MR, Manoochehri M, Kunicki ZJ, Emrani S, Rudolph JL, Huey ED, Salloway SP, Oh H; Alzheimer's Disease Neuroimaging Initiative. Utility of cerebrovascular imaging biomarkers to detect cerebral amyloidosis. Alzheimers Dement. 2024 Oct;20(10):7220-7231. doi: 10.1002/alz.14207. Epub 2024 Sep 1.

    PubMed 39219209

  • Howe MD, Caruso MR, Manoochehri M, Kunicki ZJ, Emrani S, Rudolph JL, Huey ED, Salloway SP, Oh H; Alzheimer's Disease Neuroimaging Initiative. Utility of cerebrovascular imaging biomarkers to detect cerebral amyloidosis. medRxiv [Preprint]. 2024 May 28:2024.05.28.24308056. doi: 10.1101/2024.05.28.24308056.

    PubMed 38853879

  • Xu 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

  • Rauchmann BS, Schneider-Axmann T, Perneczky R; Alzheimer's Disease Neuroimaging Initiative (ADNI). Associations of longitudinal plasma p-tau181 and NfL with tau-PET, Abeta-PET and cognition. J Neurol Neurosurg Psychiatry. 2021 Dec;92(12):1289-1295. doi: 10.1136/jnnp-2020-325537. Epub 2021 Jun 29.

    PubMed 34187867

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD), run by University of Southern California at 58 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 67 inclusion and 23 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 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 volume change of whole brain, hippocampus and other structural MRI measures (time frame: 5 Years). 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 NCT01231971, which also lists 10 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 21 Nov 2024.

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