AzTrials
AzTrials

Mild Cognitive Impairment (MCI)ADNI3NCT02854033

Alzheimer's Disease Neuroimaging Initiative 3

An observational study of Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD), run by University of Southern California at 59 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

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia… Read more about this study

Who is it for?
Ages 55 to 90 yearsHealthy volunteers can take part
How many people
1,141 participants
Where
59 sitesin 2 countries
Study dates
2 Dec 2016to 28 May 2024
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: Cognitively normal (CN), mild cognitive impairment (MCI), and mild AD dementia participants.

Who may be able to join

  • Participant with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age
  • Normal memory function documented by scoring above education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25):
  • 9 for 16 or more years of education
  • 5 for 8-15 years of education
  • 3 for 0-7 years of education
  • Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director)
Show all 57Show fewer
  • Clinical Dementia Rating = 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 at least 4 weeks:
  • Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years)
  • 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.
  • Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.
  • Abnormal memory function documented by scoring below education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25):
  • < 11 for 16 or more years of education b. ≤ 9 for 8-15 years of education c. ≤ 6 for 0-7 years of education
  • Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director)
  • Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5
  • General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the Screening Visit
  • Stability of Permitted Medications for at least 4 weeks:
  • Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years)
  • Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit
  • 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.
  • Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.n.
  • Abnormal memory function documented by scoring below education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25):
  • ≤ 8 for 16 or more years of education
  • ≤ 4 for 8-15 years of education
  • ≤ 2 for 0-7 years of education
  • Mini-Mental State Exam score between 20 and 26 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director)
  • Clinical Dementia Rating = 0.5 or 1.0
  • NINCDS (National Institute of Neurological and Communicative Disorders and Stroke) -ADRDA (Alzheimer's Disease and Related Disorders Association) criteria for probable AD
  • Stability of Permitted Medications for at least 4 weeks:
  • Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years)
  • Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit
  • 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.
  • Geriatric Depression Scale score less than 6.
  • Age between 55-90 years (inclusive).
  • Study partner who has frequent contact with the participant (i.e., minimum average of 10 hours per week) and is available to accompany the participant to all clinic visits for the duration of the protocol.
  • Visual and auditory acuity adequate for neuropsychological testing.
  • 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.
  • Modified Hachinski Ischemic Score 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
  • Agrees to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking.
  • Agrees to collection of blood for biomarker testing.
  • Agrees to at least one lumbar puncture for the collection of CSF.
  • Agrees to share genomic data and biomarker samples. Inclusion Criteria Specific to Rollover Participants"
  • The following additional inclusion criteria apply to all diagnostic categories for rollover participants only:
  • Must have been enrolled and followed in ADNI-1, ADNI-GO, or ADNI-2 for at least one year.
  • 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.

Who cannot join

  • 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 deficits or known structural brain abnormalities
  • 1. 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 deficits or known structural brain abnormalities.
  • 1. 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 deficits or known structural brain abnormalities.
  • The following additional exclusion criteria apply to all diagnostic categories:
  • Screening/Baseline MRI brain scan with evidence of infection, infarction, or other focal lesions or multiple lacunes or lacunes in a critical memory structure
  • Subjects that have any contraindications for MRI studies, including the presence of cardiac pacemakers, or metal fragments or foreign objects in the eyes, skin or body.
Show all 20Show fewer
  • 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 that could lead to difficulty complying with the protocol.
  • Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder.
  • History of schizophrenia (DSM IV criteria).
  • History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
  • Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol.
  • Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
  • Residence in a skilled nursing facility.
  • Current use of specific psychoactive medications (e.g., certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics). Current use of warfarin or other anticoagulants such as dabigatran, rivaroxaban and apixaban (exclusionary for lumbar puncture).
  • Current use of any other exclusionary medications
  • Investigational agents are prohibited 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.
  • The following criteria are exclusionary only for the AV-1451 scanning portion of the study:
  • History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with sudden death) or taking medications known to prolong the QT interval. A list of restricted medications will be provided.
  • Have an ECG obtained prior to the AV-1451 PET scan that in the opinion of the investigator is clinically significant with regard to the subject's participation in the study. Bazett's corrected QT (QTcB) interval must be evaluated and must not exceed 458 msec in males, or 474 msec in females.

Trial locations and contacts

59 sites in 2 countries.

59 sites in 2 countries

United States54 sites

  • Albany Medical College

    Albany, New York, 12208

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan, 481052967

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins University

    Baltimore, Maryland, 212242764

  • Case Western Reserve University

    Beachwood, Ohio, 441224312

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 21155804

  • Boston University School of Medicine

    Boston, Massachusetts, 21182307

  • Dent Neurologic Institute

    Buffalo, New York, 142261727

  • Ralph H. Johnson VA Health Care System

    Charleston, South Carolina, 29401

  • Northwestern University

    Chicago, Illinois, 606113010

  • Rush University Medical Center

    Chicago, Illinois, 606123806

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas, Southwestern MC at Dallas

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Kansas

    Fairway, Kansas, 66205

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist

    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 California, San Diego

    La Jolla, California, 920371707

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 891060100

  • University of Kentucky

    Lexington, Kentucky, 405042681

  • Long Beach VA Neuropsychiatric Research Program

    Long Beach, California, 90822

  • University of Southern California

    Los Angeles, California, 900335310

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 537920001

  • Wien Center for Clinical Research

    Miami Beach, Florida, 331402877

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Yale University School of Medicine

    New Haven, Connecticut, 65103330

  • New York University Medical Center

    New York, New York, 100166055

  • Mount Sinai School of Medicine

    New York, New York, 100296552

  • Columbia University

    New York, New York, 10032

  • Nathan Kline Institute for Psychiatric Research

    Orangeburg, New York, 109621159

  • VA Palo Alto HSC / Stanford School of Medicine

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University

    Portland, Oregon, 972393011

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Butler Hospital Memory and Aging Program

    Providence, Rhode Island, 02906

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 559050001

  • University of Rochester

    Rochester, New York, 14620

  • University of California, San Francisco

    San Francisco, California, 94158

  • Washington University, St. Louis

    St Louis, Missouri, 631082215

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • University of South Florida - Health Byrd Alzheimer Institute

    Tampa, Florida, 336134808

  • University of California, Davis

    Walnut Creek, California, 945985900

  • Georgetown University

    Washington D.C., District of Columbia, 200072145

  • Howard University

    Washington D.C., District of Columbia, 200600001

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada5 sites

  • Parkwood Institute

    London, Ontario, N6C 0A7

  • St. Joseph's Health Center - Cognitive Neurology

    London, Ontario, N6C 4R3

  • Jewish General Hospital Memory Clinic

    Montreal, Quebec, H3T 1E2

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University of British Columbia, Clinic for AD & Related

    Vancouver, British Columbia, V6T1Z3

Other trials in Canada

About this study

Official title: Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.

Read the detailed description

The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia. ADNI3 continues the previously funded AD Neuroimaging Initiative (ADNI1, ADNI-GO, and ADNI-2), and remains a public/private collaboration between academia and industry to study biomarkers of AD. ADNI will continue to inform the neuroscience of AD, identify diagnostic and prognostic markers, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios.

This is multi-center, a non-randomized, natural history, non-treatment study. 1,070-2,000 total participants will be enrolled across three cohorts: cognitively normal* (CN), mild cognitive impairment (MCI) and mild Alzheimer's Disease (AD) dementia. Participants between the ages of 55-90 (inclusive) will be enrolled at 59 sites in the United States and Canada. Approximately, 700 - 800 will be rollover participants from previous ADNI studies, and 370 - 1200 will be newly enrolled. Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across the three cohorts.

Participants will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI scans and cerebral spinal fluid (CSF) collection for up to 5 years.

*currently recruiting non-Caucasian participants only for the cognitively normal cohort.

Keywords
amyloid, plaques, neuroimaging, biomarkers, cognition disorder, early detection, 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.

Study groups in NCT02854033
Study groupRoleWhat they receive
Cognitively Normal (CN)135-500 newly enrolled participants with no apparent memory problems, and 295-300 cognitively normal participants followed from the ADNI2 study. Currently recruiting non-Caucasian participants only for the normal cognition group.
Mild Cognitive Impairment (MCI)150 - 515 newly enrolled participants with mild cognitive impairment (MCI), and 275-320 MCI participants followed from the ADNI2 study.
Mild Alzheimer's Disease (AD) dementia85 - 185 newly enrolled participants with mild Alzheimer's disease (AD) dementia, and 130 - 150 mild AD participants followed from the ADNI2 study.

What is being measured

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

  1. Rate of change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13)

    The ADAS-Cog is an in-person examiner-administered, structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained.

    Measured: 5 years

  2. Rate of change in cognition as measured by the Logical Memory Test I and II

    Measured: 5 years

  3. Rate of change in cognition as measured by the Mini-Mental State Examinations (MMSE)

    The MMSE scale evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two overlapping pentagons.

    Measured: 5 years

Secondary outcomes (12)

  1. Rate of change in cognition as measured by the Cogstate Brief Battery (CBB)

    The Cogstate Brief battery (CBB) is a brief (10-15 minute) computerized cognitive battery developed by Cogstate (Cogstate Ltd. New Haven, CT, USA) that measures attention, speed of information processing, working memory and learning.

    Measured: 5 years

  2. Rate of change in cognition as measured by the American National Adult Reading Test (ANART)

    The ANART estimates premorbid verbal intelligence (VIQ) in patients with dementia.

    Measured: 5 years

  3. Rate of change in cognition as measured by the Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment test (MoCA) is a cognitive assessment designed to detect participants at the MCI stage of cognitive dysfunction.

    Measured: 5 years

  4. Rate of change in cognition as measured by the Rey Auditory Verbal Learning Test

    The AVLT is a list-learning task, which assesses multiple cognitive parameters associated with learning and memory.

    Measured: 5 years

  5. Rate of change in cognition as measured by the Trail Making Test: A and B

    Measured: 5 years

  6. Change in tau deposition as measured by 18F-AV-1451

    Measured: 5 years

  7. Change in amyloid deposition as measured by Florbetapir

    Measured: 5 years

  8. Change in amyloid deposition as measured by Florbetaben

    Measured: 5 years

  9. Rate of conversion to MCI or dementia due to AD

    Measured: 5 years

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

    Measured: 5 years

  11. Change in Cerebral Spinal Fluid (CSF) Tau Biomarkers

    Measured: 5 years

  12. Change in brain structure using magnetic resonance imaging (MRI)

    Measured: 5 years

Timeline

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

  1. First posted3 Aug 2016 (estimated)
  2. Study start2 Dec 2016
  3. Primary completion28 May 2024
  4. Study completion28 May 2024

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
1,141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02854033
Sponsor's protocol ID
ATRI-001
Other IDs
U01AG024904
Acronym
ADNI3
Status last verified
Mar 2026
First submitted
27 Jul 2016
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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

  • Bullich S, Roe-Vellve N, Marquie M, Landau SM, Barthel H, Villemagne VL, Sanabria A, Tartari JP, Sotolongo-Grau O, Dore V, Koglin N, Muller A, Perrotin A, Jovalekic A, De Santi S, Tarraga L, Stephens AW, Rowe CC, Sabri O, Seibyl JP, Boada M. Early detection of amyloid load using 18F-florbetaben PET. Alzheimers Res Ther. 2021 Mar 27;13(1):67. doi: 10.1186/s13195-021-00807-6.

    PubMed 33773598

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 59 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 57 inclusion and 20 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 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 change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13) (time frame: 5 years). The study lists 3 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 NCT02854033, which also lists 7 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 11 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in