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ACT-AD

CompletedPhase 2Results posted

A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease

A Randomized, Placebo-Controlled, Translational Study of ATH-1017 in Subjects With Mild to Moderate Alzheimer's Disease

Lead sponsor

LeonaBio

Asset

ATH-1017

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD / moderate AD dementia•MMSE 14-24•Study partner/caregiver required

Primary endpoint

•Event-related Potential (ERP) P300 Latency

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

Other grant18PTC-R-589358Alzheimer's Association

Nih1R01AG068268-01

Org study IDATH-1017-AD-0202

NCT IDNCT04491006

Secondary IDU1111-1255-9714WHO (UTN)

Timeline

Milestones

Study first posted2020-07-29actual

Study start2020-11-23actual

Primary completion2022-05-20actual

Study completion2022-05-20actual

Last update posted2023-06-12actual

Results first posted2023-06-12actual

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

Key Inclusion Criteria:

•Age 55 to 85 years

•Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening

•Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)

•Reliable and capable support person/caregiver

•Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:

-Treatment-naïve, OR

-Subjects are on a stable, approved dose of an AChEI (except for donepezil at 23 mg PO) for at least 3 months before Screening OR

-Subjects who received an AChEI in the past and discontinued 4 weeks prior to Screening

Exclusion criteria

•History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia

•History of unexplained loss of consciousness, and epileptic fits (unless febrile)

•Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD

•History of brain MRI scan indicative of any other significant abnormality

•Hearing test result considered unacceptable for auditory ERP P300 assessment

•Diagnosis of severe major depressive disorder even without psychotic features

•Significant suicide risk

•History within 2 years of Screening, or current diagnosis of psychosis

•Myocardial infarction or unstable angina within the last 6 months

•Clinically significant (in the judgment of the investigator) cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)

•Subject has either hypertension (supine diastolic blood pressure > 95 mmHg), or symptomatic hypotension in the judgment of the investigator

•Clinically significant ECG abnormality at Screening

•Renal insufficiency (serum creatinine > 2.0 mg/dL)

•Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal, or Child-Pugh class B and C

•Malignant tumor within 3 years before Screening

•Memantine in any form, combination or dosage within 4 weeks prior to Screening

•Donepezil at 23 mg PO

•The subject has received active amyloid or tau immunization (i.e., vaccination for Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for Alzheimer's disease) within 6 months of Screening

Endpoints (4)

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.

Memory

4 endpoints

Primary/protocol endpoint

Event-related Potential (ERP) P300 Latency at Baseline

Time frame:At Baseline (Day 1)

event count, event

Primary/registry result

Event-related Potential (ERP) P300 Latency at Baseline

Time frame:At Baseline (Day 1)

event count, event

Posted result

Group	Value (mean), Milliseconds (ms)	Standard deviation
Placebon=23 Participants	361.5	32.23
ATH-1017 40 mgn=26 Participants	382.3	40.18
ATH-1017 70 mgn=25 Participants	375.3	35.77

Secondary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline

Time frame:At Baseline (Day 1)

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline

Time frame:At Baseline (Day 1)

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Placebon=23 Participants	23.0	7.96
ATH-1017 40 mgn=25 Participants	22.4	8.94
ATH-1017 70 mgn=25 Participants	20.7	7.18

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

McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
PMID21514250via BACKGROUND

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.