TerminatedPhase 2Results posted

ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)

A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies

Lead sponsor

LeonaBio

Asset

ATH-1017

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•Parkinson's disease dementia•MoCA 11-23•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-PD-0201

NCT IDNCT04831281

Timeline

Milestones

Study first posted2021-04-05actual

Study start2022-01-20actual

Primary completion2023-04-19actual

Study completion2023-04-19actual

Last update posted2025-03-04actual

Results first posted2025-03-04actual

Assets

Drug assets

ATH-1017

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age40 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects with confirmed diagnosis of Parkinson's disease or Dementia with Lewy Bodies

•MoCA score 11 to 23, inclusive, at screening

•Probable Parkinson's Disease Dementia or Lewy Body Dementia

•BMI between ≥ 16and ≤ 35 kg/m2 for females and between≥ 18 and ≤ 35 kg/m2 for males at Screening

•Reliable and capable support person/caregiver, who is willing to accept responsibility for supervising the treatment or, if required, administering study drug, and assessing the condition of the subject throughout the study in accordance with all protocol requirements

Exclusion criteria

•Hoehn-Yahr stage 5

•History of significant neurological disease other than PDD or DLB that may affect cognition at onset of dementia

•Subjects on deep brain stimulation

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

•History of unexplained loss of consciousness, and epileptic fits

•Hearing test result considered unacceptable for auditory ERP P300 assessment

•Diagnosis of severe major depressive disorder even without psychotic features (GDS score [15-item scale] >7 at Screening)

•Significant suicide risk based on C-SSRS

•Significant psychosis (according to Diagnostic and Statistical Manual of Mental Disorders)

•Moderate or severe substance abuse disorder (according to DSM-5)

•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)

•Clinically significant ECG abnormality at Screening

•Chronic kidney disease (eGFR < 45 mL/min using Cockcroft-Gault formula)

•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 at any dose or combination

•Donepezil at 23 mg

Endpoints (6)

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

Other (unclassified)

Memory

2 endpoints

Secondary/protocol endpoint

Event-related Potential (ERP) P300 Latency at Baseline

Time frame:Baseline

event count, event

Secondary/registry result

Event-related Potential (ERP) P300 Latency at Baseline

Time frame:Baseline

event count, event

Posted result

Group	Value (mean), Millisecond (ms)	Standard deviation
Placebon=9 Participants	381.84	51.739
ATH-1017 40 Milligrams (mg)n=7 Participants	373.19	18.669
ATH-1017 70 mgn=9 Participants	367.84	45.635

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Global Statistical Test (GST) Score at Baseline

Time frame:Baseline

ADAS-Cog

change from baseline, improvement

Primary/registry result/low confidence

Global Statistical Test (GST) Score at Baseline

Time frame:Baseline

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Z-score	Standard deviation
Placebon=9 Participants	-0.222	0.6365
ATH-1017 40 mgn=7 Participants	0.332	0.6337
ATH-1017 70 mgn=9 Participants	-0.036	1.0050

Secondary/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Baseline

Time frame:Baseline

ADAS-Cog

descriptive

Secondary/registry result/low confidence

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Baseline

Time frame:Baseline

ADAS-Cog

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=9 Participants	16.9	6.94
ATH-1017 40 Milligrams (mg)n=7 Participants	29.7	10.03
ATH-1017 70 mgn=9 Participants	23.8	11.49

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.