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TerminatedPhase 2 / PHASE3Results posted

Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease

Lead sponsor

LeonaBio

Asset

ATH-1017

Listed sites

1

Recruiting sites

-

Enrollment

423

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Treatment-Emergent Adverse Events [Safety and Tolerability]

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

Org study IDATH-1017-AD-0203
NCT IDNCT04886063

Timeline

Milestones

Study first posted2021-05-13actual
Study start2021-06-30actual
Primary completion2024-10-23actual
Study completion2024-10-23actual
Last update posted2025-04-01actual
Results first posted2025-04-01actual

Assets

Drug assets

ATH-1017

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Subject has completed the Week 26 visit of either of the two blinded parent studies (ATH-1017-AD-0201 or ATH-1017-AD-0202).
•Reliable and capable support person/caregiver who is willing to accept responsibility for supervising the daily treatment or, if required, administering study drug.
•Subject capable of giving signed informed consent, or by a legally acceptable representative.
•Subjects must be in generally good health.
•Male subjects and their partners must agree to continue to use a double-barrier method of contraception during the study, including the follow-up period, unless the partner is not of childbearing potential

Exclusion criteria

•Subject has experienced a serious adverse event during the parent study, which could present an increased safety risk during the open label extension.
•New diagnosis of severe major depressive disorder even without psychotic features.
•Any subject with formalized delusions or hallucinations.
•Significant suicide risk.
•Newly-diagnosed malignant tumor, except for the following conditions that are stable in the judgement of the investigator:
-Adequately treated squamous and basal cell carcinoma, or squamous and basal cell carcinoma in situ
-Prostate carcinoma in situ

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time frame:Up to 173 weeks (study termination)

event count, event

Primary/registry result

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time frame:Up to 173 weeks (study termination)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
ATH-1017 40 Milligrams (mg)At least 1 TEAEn=423 Participants323-
No TEAEsn=423 Participants100-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.