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Preclinical Alzheimer's DiseasePhase 2ATPNCT06957418

Alzheimer's Tau Platform: Master Protocol

A Phase 2 study testing AADvac1 and Tau2 in people with Preclinical Alzheimer's Disease and Alzheimer Disease, run by Paul S. Aisen at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of the Alzheimer's Tau Platform (ATP) is to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease. Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
AADvac1 and Tau2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
7 sitesUnited States
Study dates
6 Jul 2026to 31 Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documentation of the participant's informed consent to study procedures (including APOE genotyping).
  • Ages 50-80 years (inclusive). Participants between the ages of 50 and 60 (inclusive) must be mildly impaired at screening (global CDR=0.5 and maximum CDR-SB <1.5
  • Cognitively unimpaired (preclinical AD with a global CDR=0) or mildly impaired (prodromal AD with a global CDR=0.5 and maximum CDR-SB <1.5).
  • MMSE score at screening of 20-30 (inclusive) with educational adjustments:
  • If <12 years of education, MMSE required to be >20.
  • If 13 to 15 years (inclusive) of education, MMSE required to be >22.
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  • If >16 years of education, MMSE required to be >24.
  • Plasma biomarker result at screening that demonstrate the presence of amyloid pathology, consistent with preclinical-prodromal AD.
  • Elevated brain tau on PET (MTL or NEO tau SUVr >1.2) at screening.
  • Elevated brain amyloid on PET (centiloids > 40) at screening.
  • Stable doses of permitted medications as described per protocol for a minimum of 30 days prior to screening.
  • Resides at home or in the community (assisted living acceptable).
  • In the opinion of the site PI, has a study partner able and willing to provide accurate information (including clinical symptoms and medical history) about the participant and participate in study visits and informant-based assessments (usually requires at least 5 hours of contact per week) for the duration of the study.
  • As assessed by the site PI, participant is likely to be able to comply with the protocol for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy (English or Spanish) sufficient for compliance with the required testing procedures.
  • Must complete all screening evaluations as outlined per protocol.

Who cannot join

  • Females who are lactating or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study.
  • Females of childbearing potential who did not use a highly effective method of contraception within 28 days of screening and/or are not willing to use highly effective method of contraception for the duration of their participation in the study. Males who are sexually active with a female of childbearing potential and do not agree to use barrier methods of contraception (condoms with spermicide) during the trial and for 6 months after the last dose of study drug unless the female is using a highly effective method of contraception.
  • Lacks good venous access such that multiple blood draws would be precluded.
  • Weighs less than 40kg, or more than 136kg at screening.
  • Suspected or known allergic reactions, adverse reactions, or hypersensitivity to any components of the study intervention for any of the available regimen.
  • Previous treatment with the study intervention from any available regimen unless it can be confirmed the participant received placebo in the previous study.
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  • Prior or current treatment with a prohibited medication as described per protocol.
  • Enrollment in another investigational study as described per protocol. Participants enrolled in an observational study may be permitted with Medical Monitor review and approval.
  • Contraindications to MRI studies, including metal (ferromagnetic) implants, a cardiac pacemaker that is not compatible with MRI, and/or severe claustrophobia.
  • MRI scan at screening showing a single area of cerebral vasogenic edema, superficial siderosis, or showing more than four (4) cerebral microhemorrhages (defined as 10 mm or less at the greatest diameter); evidence of a prior or current macrohemorrhage (greater than 10 mm at greatest diameter, also referred to as intracerebral hemorrhage >1 cm within this protocol); cerebral contusion; encephalomalacia; aneurysms greater than 6 mm, or any aneurysms that have not been stable in size for the past 2 years; vascular malformations that are at high risk for hemorrhage; infectious lesions; evidence of multiple lacunar infarcts (that in the opinion of the investigator, may impact cognition); stroke involving a major vascular territory; severe small vessel disease; severe diffuse white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 cm at their greatest diameter need not be exclusionary).
  • Contraindications to tau and/or amyloid PET scan imaging and/or use of MK6240 and/or 18F-NAV-4694 (flutafuranol).
  • For participants undergoing an LP as part of the optional longitudinal CSF biomarker sub-study, contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; international normalized ratio (INR) >1.4 or other coagulopathy; platelet count of <120,000/μL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of LP NOTE: low dose aspirin is permitted; degenerative arthritis of the lumbar spine; suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma.
  • Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of study drug (e.g., moderate and/or severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per the site PI's judgement.
  • History of severe allergic reaction (e.g., anaphylaxis) including, but not limited to: severe allergic reaction to previous vaccines, foods, and/or medications.
  • Hospitalization within 30 days prior to screening or baseline.
  • Clinically significant infections or major surgical operation within 3 months prior to screening.
  • History of chronic or recurrent infections judged to be clinically significant by the site PI and which would potentially hamper the evaluation of efficacy and safety assessments.
  • Myocardial infarction within 1 year prior to baseline, unstable angina pectoris, or significant coronary artery disease.
  • History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in-situ, in-situ prostate cancer, or in-situ breast cancer, which have been fully removed and are considered cured.
  • History of inflammatory neurological disorders.
  • History or presence of immunological or inflammatory conditions, including neurological disorders, judged to be clinically significant by the site PI.
  • History of meningitis or meningoencephalitis.
  • History of moderate or severe traumatic brain injury.
  • History or presence of uncontrolled seizures. If history of seizures, they must be well controlled with no occurrence of seizures in the 2 years prior to study screening. The use of antiepileptic medications is permitted (see section 6.5.2).
  • Concomitant or past history of psychiatric or neurologic disorder other than those considered to be related to AD (e.g., head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks, hemorrhagic and/or non-hemorrhagic stroke).
  • DSM-5 criteria for drug or alcohol abuse or dependence currently met within the past 5 years.
  • Significant risk of suicide defined, using the C-SSRS, as the participant answering "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behavior within the past 6 months.
  • Clinically significant abnormal vital signs including sustained sitting blood pressure >160/90 mm Hg.
  • Participants with diabetes mellitus with hemoglobin A1c (HbA1c) levels of >7.5%.
  • In the opinion of the site PI, clinically significant deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, including, but not limited to:
  • hematocrit less than 35% for those with male biological sex and less than 32% for those with female biological sex.
  • absolute neutrophil cell count <1500/uL (with the exception of a chronic benign neutropenia).
  • absolute lymphocyte count <900/uL.
  • platelet cell count of <100,000/uL.
  • INR >1.4 or other coagulopathy, confirmed by repeat (not applicable for participants on anticoagulation).
  • Participants with a known history of human immunodeficiency virus infection (HIV-1 and 2).
  • Participants with known history of acute/chronic hepatitis B or C.
  • Any other clinically significant, advanced, or unstable disease that may interfere with outcome evaluations, such as:
  • Chronic liver disease.
  • Respiratory insufficiency.
  • Renal insufficiency defined as estimated glomerular filtration rate (eGFR) <50 mL/min based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
  • Bradycardia (<50/min) or tachycardia (>100/min). Bradycardia >40/min and <50/min may be permitted with review and approval by the Medical Monitor.
  • Clinically significant arrhythmias or other clinically significant abnormalities on ECG at screening (minor abnormalities documented as clinically insignificant by the site PI are allowed).
  • Any condition, which in the opinion of the site PI, Coordinating Center, or Project Lead/Protocol PI, makes the participant unsuitable for inclusion.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

ATP Recruitment and Retention (RER) Team contact

213-821-0569

adtau-participate@usc.edu

7 sites in 1 country

United States7 sites, 7 recruiting

  • Brigham and Women's Hospital Center for Alzheimer Research and Treatment

    Boston, Massachusetts, 02115

    Gad Marshall, MD

    Recruiting

  • University of Kentucky Sanders Brown Center on Aging

    Lexington, Kentucky, 40504

    Gregory Jicha, MD, PhD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

    Patricia Andrews, MD

    Recruiting

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

    Po-Heng Tsai, MD

    Recruiting

  • Butler Hospital Memory and Aging Program

    Providence, Rhode Island, 02906

    Meghan Riddle, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94158

    Peter Ljubenkov, MD

    Recruiting

  • Harborview Medical Center, University of Washington

    Seattle, Washington, 98104

    Michael Rosenbloom, MD

    Recruiting

Other trials in United States

About this study

Official title: The Alzheimer's Disease Tau Platform Clinical Trial

The goal of the Alzheimer's Tau Platform (ATP) is to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease.

This platform trial allows for the simultaneous testing of multiple tau therapies under a shared master protocol. This means that multiple investigational products will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen.

Read more

The main questions the platform trial aims to answer are:

  • Does a tau-directed therapy, alone or in combination with donanemab, reduce tau buildup in the brain compared to donanemab alone?
  • Does a tau-directed therapy, alone or in combination with donanemab, slow disease progression based on brain imaging, fluid biomarkers, and measures of memory and thinking?

Participants will:

  • Be randomized to a treatment regimens, each containing different tau therapies. The exact number of treatment regimens that will active at the time of screening will change over time.
  • Receive donanemab or placebo for 6 months, followed by 24 months of tau therapy alone or in combination with donanemab.
  • Undergo regular cognitive testing, brain scans (MRI/PET), and biomarker assessments over 30 months

Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized to one of three arms: (1) tau therapy alone, (2) a combination of donanemab and tau therapy, or (3) donanemab alone.

New regimens will be continuously added as new investigational products become available. The Alzheimer's Tau Platform Trial will enroll additional participants as each new regimen becomes available.

ATP will launch with one regimen: Regimen A: AADvac1. In the future, Regimen B ("Tau2") will launch with a second tau directed therapy.

Being tested
AADvac1, Tau2
Keywords
Alzheimer's disease, Preclinical Alzheimer's, Prodromal Alzheimer's, Mild cognitive impairment (MCI), Neurodegeneration, Dementia, Tau-directed therapy, Monoclonal antibody, Anti-tau therapy, Combination therapy, Immunotherapy, anti-amyloid mAb
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Nerve Degeneration, Dementia

What participants receive

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

  • AADvac1Drug

    AADvac1 tau directed therapy

  • Tau2Drug

    Tau2 directed therapy

Study groups in NCT06957418
Study groupRoleWhat they receive
Regimen A: AADvac1ExperimentalParticipants are randomized to receive either AADvac1, combination AADvac1 with donanemab, or donanemab alone (active control)
Receives: Drug: AADvac1
Regimine B: Tau2ExperimentalParticipants are randomized to receive either Tau2 directed monotherapy, combination Tau2 with donanemab, or donanemab alone (active control)
Receives: Drug: Tau2

What is being measured

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

  1. Reduction of brain tau deposition as measured by tau positron emission tomography (PET)

    To determine whether at least one tau therapy, either alone or in combination with donanemab, will produce a greater reduction in brain tau deposition as measured by 18F-MK-6240 PET compared to donanemab alone.

    Measured: 0, 6, 18 and 30 months

Secondary outcomes (1)

  1. Disease progression as measured by plasma biomarkers

    To assess whether at least one tau therapy, either alone or in combination with donanemab slows disease progression as measured by plasma biomarkers. Plasma biomarkers are measured by the ratio of amyloid-beta 42 to amyloid-beta 40 (Aβ42/40), phosphorylated tau at threonine 217 (ptau217), neurofilament light chain (NfL), or glial fibrillary acid protein (GFAP).

    Measured: 30 months

Timeline

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

  1. First posted4 May 2025
  2. Study start6 Jul 2026
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
As new investigational products become available, additional regimens will be added to the Alzheimer's Tau Platform trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06957418
Sponsor's protocol ID
ATRI-014
Other IDs
R01AG078457
Acronym
ATP
Status last verified
Oct 2026
First submitted
25 Apr 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AADvac1 and Tau2 in people with Preclinical Alzheimer's Disease and Alzheimer Disease, run by Paul S. Aisen at 7 sites in United States.

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 15 inclusion and 44 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: looking for participants now, as of the sponsor's last update on 26 Oct 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ATP Recruitment and Retention (RER) Team (213-821-0569, adtau-participate@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of brain tau deposition as measured by tau positron emission tomography (PET) (time frame: 0, 6, 18 and 30 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 NCT06957418.

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 26 Oct 2026.

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