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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 March 2025
• Main ID: NCT04831281
• Date of registration: 01/04/2021
• Prospective Registration: Yes
• Primary sponsor: Athira Pharma
• Public title: ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
• Scientific title: A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies
• Date of first enrolment: January 20, 2022
• Target sample size: 28
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT04831281
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

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


Age minimum: 40 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease Dementia

Dementia With Lewy Bodies

Intervention(s)

Drug: Placebo

Drug: ATH-1017

Primary Outcome(s)

Global Statistical Test (GST) Score at Baseline [Time Frame: Baseline]

Secondary Outcome(s)

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Baseline [Time Frame: Baseline]

Event-related Potential (ERP) P300 Latency at Baseline [Time Frame: Baseline]

Secondary ID(s)

ATH-1017-PD-0201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/03/2025
• URL: https://clinicaltrials.gov/ct2/show/results/NCT04831281