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CompletedPhase 2

Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD

A Phase 2 Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

Asset

T-817MA

Listed sites

37

Recruiting sites

-

Enrollment

221

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•MCI due to AD•MMSE 24-30•AD symptomatic therapy: stable ≥3 months•MRI contraindications excluded

Primary endpoint

•Phosphorylated tau 181 (p-tau181)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2018-003567-66
NCT IDNCT04191486
Org study IDT817MAEU201

Timeline

Milestones

Study first posted2019-12-09actual
Study start2019-12-24actual
Primary completion2023-02-22actual
Study completion2023-03-20actual
Last update posted2023-10-23actual

Assets

Drug assets

T-817MA

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Key Inclusion Criteria:

•Female of non-childbearing potential or male, ages 50 to 80 years (inclusive)
•MCI due to AD or mild AD per NIA-AA diagnostic criteria (Jack et al., 2018), with MMSE 24 to 30 (inclusive)
•CSF results at Screening consistent with the presence of Aß and p-tau181 abnormality (≤1000 pg/ml for Aß, ≥19 pg/ml for p-tau181).
•Taking stable dose of AChE Inhibitor (donepezil, galantamine or rivastigmine) at least for 3 months prior to randomization, or not taking any AChE Inhibitors

Exclusion criteria

•MRI of the brain within the previous 2 years that showed pathology that would be inconsistent with a diagnosis of AD
•Taking memantine
•Any contraindications to lumbar puncture
•Any contraindications to MRI

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers
5
Fluid / digital biomarkers
5
Neurodegeneration biomarkers
3
Safety / tolerability / PK
3
Global cognition
1
Tau biomarkers
1
Neuroimaging
1
Other (unclassified)
1

Global cognition

1 endpoint
Secondary/protocol endpoint

The change in cognitive function assessed by CDR-sb and working memory and attention domain as measured by the CFC from Baseline to Weeks 28, 52 and 78

Time frame:Baseline to Weeks 28, 52 and 78

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Amyloid biomarkers

5 endpoints
Secondary/protocol endpoint

The change in the CSF Aβ1-42 from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

change from baseline, improvement

Secondary/protocol endpoint

The change in the CSF Aβ1-40 from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

change from baseline, improvement

Secondary/protocol endpoint

The change in the CSF Aβ1-42/Aβ1-40 ratio from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

change from baseline, improvement

Secondary/protocol endpoint

The change in the plasma Aβ1-42 from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

change from baseline, improvement

Secondary/protocol endpoint

The change in the plasma Aβ1-40 from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

change from baseline, improvement

Tau biomarkers

1 endpoint
Secondary/protocol endpoint

The change in the CSF total tau from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

change from baseline, improvement

Neurodegeneration biomarkers

3 endpoints
Secondary/protocol endpoint

The change in the CSF neurofilament light (NFL) from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

Neurofilament light (NfL)

change from baseline, improvement

Secondary/protocol endpoint

The change in the CSF neurogranin from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

change from baseline, improvement

Secondary/protocol endpoint

The change in the plasma NFL from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

Neurofilament light (NfL)

change from baseline, improvement

Neuroimaging

1 endpoint
Secondary/protocol endpoint

The change in brain volume (total brain volume (TBV), ventricular volume and hippocampal volume) and cortical thickness measured by vMRI from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

change from baseline, improvement

Fluid / digital biomarkers

5 endpoints
Primary/protocol endpoint

The change in the CSF p-tau181 from Baseline to Week 78

Time frame:Baseline to Week 78

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Secondary/protocol endpoint

The change in the CSF p-tau181 from Baseline to Week 52

Time frame:Baseline to Week 52

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Secondary/protocol endpoint

The change in the CSF p-tau217 from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Secondary/protocol endpoint

The change in the CSF YKL-40 from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

change from baseline, improvement

Secondary/protocol endpoint

The change in alpha/theta ratio measured by the EEG from Baseline to Weeks 52 and 78

Time frame:Baseline to Weeks 52 and 78

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Safety as assessed by the occurrence of AEs, clinical laboratory tests, vital signs, physical examinations, ECGs

Time frame:Screening to Week 82

descriptive

Secondary/protocol endpoint

Population PK analysis of T-817MA with assessment of maximum plasma concentration (Cmax)

Time frame:Weeks 16, 28, 40, and 65

concentration, descriptive

Secondary/protocol endpoint

Population PK analysis of T-817MA with assessment of minimum plasma concentration (Cmin)

Time frame:Weeks 16, 28, 40, and 65

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Population PK analysis of T-817MA with assessment of total daily exposure (AUC0-24h)

Time frame:Weeks 16, 28, 40, and 65

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.