LIFT-AD

CompletedPhase 2 / PHASE3Results posted

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

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

Lead sponsor

LeonaBio

Asset

ATH-1017

Listed sites

Recruiting sites

Enrollment

554

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

•ADAS-Cog

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-0201

NCT IDNCT04488419

Timeline

Milestones

Study first posted2020-07-28actual

Study start2020-09-28actual

Primary completion2024-07-15actual

Study completion2024-07-15actual

Last update posted2025-04-04actual

Results first posted2025-04-04actual

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)

•Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m2 at Screening

•Reliable and capable support person/caregiver

•Treatment-free (subjects not receiving acetylcholinesterase inhibitor [AChEI] treatment), defined as:

-Treatment-naïve, OR

-Subjects who received an AChEI in the past and discontinued at least 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

•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

•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 cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)

•Subject has either hypertension or symptomatic hypotension

•Clinically significant ECG abnormality at Screening

•Chronic kidney disease with estimated glomerular filtration rate (eGFR) <45 mL/min

•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

•Acetylcholinesterase inhibitors in any dosage form

•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 (8)

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

Function / daily living

Memory

Neurodegeneration biomarkers

Memory

2 endpoints

Secondary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) Change From Baseline

Time frame:Baseline and Week 26

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) Change From Baseline

Time frame:Baseline and Week 26

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=144 Participants	-0.39	0.54
ATH-1017 40 Milligrams (mg)n=143 Participants	-1.09	0.56

Function / daily living

4 endpoints

Primary/protocol endpoint

Global Statistical Test (GST) Score

Time frame:Baseline and Week 26

ADAS-Cog

change from baseline, improvement

Primary/registry result

Global Statistical Test (GST) Score

Time frame:Baseline and Week 26

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Z-score	Standard error
Placebon=144 Participants	-0.126	0.0683
ATH-1017 40 Milligrams (mg)n=143 Participants	-0.208	0.0707

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-Item Version (ADCS-ADL23) Change From Baseline

Time frame:Baseline and Week 26

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-Item Version (ADCS-ADL23) Change From Baseline

Time frame:Baseline and Week 26

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=144 Participants	-0.02	0.65
ATH-1017 40 Milligrams (mg)n=143 Participants	0.65	0.67

Neurodegeneration biomarkers

2 endpoints

Secondary/protocol endpoint

Plasma Neurofilament Light Chain (NfL) Concentrations Change From Baseline

Time frame:Baseline and Week 26

Neurofilament light (NfL)

change from baseline, improvement

Secondary/registry result

Plasma Neurofilament Light Chain (NfL) Concentrations Change From Baseline

Time frame:Baseline and Week 26

Neurofilament light (NfL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), picogram / milliter	Standard error
Placebon=144 Participants	2.95	2.49
ATH-1017 40 Milligrams (mg)n=143 Participants	-0.96	2.48

Publications (2)

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.