Parkinson Disease DementiaPhase 2NCT04831281
ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
A Phase 2 study testing ATH-1017 in people with Parkinson Disease Dementia and Dementia With Lewy Bodies, run by LeonaBio at 10 sites in United States.
Trial summary
This study is designed to evaluate the safety and treatment effects of fosgonimeton (ATH-1017) in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized treatment duration of 26 weeks. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease Dementia, Dementia With Lewy Bodies
- What is being tested?
- ATH-1017
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 10 sitesUnited States
- Study dates
- 20 Jan 2022to 19 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Northwest Clinical Research Center
Bellevue, Washington, 98007
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
iResearch Atlanta, LLC
Decatur, Georgia, 30030
QUEST Research Institute
Farmington Hills, Michigan, 48334
Evergreen Health Research
Kirkland, Washington, 98034
Keystone Clinical Studies LLC
Plymouth Meeting, Pennsylvania, 19462
Summit Research Network
Portland, Oregon, 97210
Center for Cognitive Health
Portland, Oregon, 97225
Inland Northwest Research LLC
Spokane, Washington, 99202
Premiere Research Institute
West Palm Beach, Florida, 33407
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies
This study is designed to evaluate the safety and treatment effects of fosgonimeton (ATH-1017) in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized treatment duration of 26 weeks.
Read the detailed description
The study is designed to evaluate the safety and treatment effects of ATH-1017 in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized, double-blind, placebo-controlled, parallel-arm treatment duration of 26 weeks.
- Being tested
- ATH-1017, Placebo
- Keywords
- Parkinson's Disease Dementia, Dementia with Lewy Bodies, Dementia, HGF/MET, Hepatocyte Growth Factor, Neurotrophic, ATH-1017, Event-Related Potential, ERP P300
- Medical subject headings
- Lewy Body Disease, Dementia, Deafness, Autosomal Recessive 39
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH-1017Drug
Daily subcutaneous injection of ATH-1017 in a pre-filled syringe
PlaceboDrug
Daily subcutaneous injection of Placebo in a pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| 40mg Dose | Experimental | Daily subcutaneous injection of 40mg ATH-1017 Receives: Drug: ATH-1017 |
| 70mg Dose | Experimental | Daily subcutaneous injection of 70mg ATH-1017 Receives: Drug: ATH-1017 |
| Placebo | Placebo comparator | Daily subcutaneous injection of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Statistical Test (GST) Score at Baseline
The Global Statistical Test (GST) score is a composite of the change from baseline (CFB) z-scores to Week 26 in the Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13-Item Version (ADAS-Cog13; range 0-85; higher scores indicate greater impairment) and Event Related Potential P300 Latency (ERP P300; longer latency (milliseconds) indicates greater impairment). This composite approach was used to assess overall change in disease status and treatment effects of ATH-1017.
The GST score was defined as a single outcome variable based on standardizing and combining individual patient-level z-score of change from baseline cognition (ADAS-Cog13) and ERP P300 latency scores. The between-group difference was calculated by subtracting the mean GST score for placebo from the mean GST score for ATH-1017. A negative value based on GST scores (ATH-1017 minus placebo) indicates a favorable response to ATH-1017, while a positive value favors placebo.
Measured: Baseline
Secondary outcomes (2)
Event-related Potential (ERP) P300 Latency at Baseline
ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit.
Measured: Baseline
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Baseline
The Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13-Item Version (ADAS-Cog13) is designed to measure cognitive symptom change. The test comprises 9 performance items and 4 clinician-rated items (total score ranging from 0 to 85). Higher scores indicate more severe cognitive impairment.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start20 Jan 2022
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Why it stopped: Enrollment ended early due to study design limitations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson Disease DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- LeonaBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831281
- Sponsor's protocol ID
- ATH-1017-PD-0201
- Status last verified
- Feb 2025
- First submitted
- 1 Apr 2021
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies
- ClinicalTrials.gov ID
- NCT04831281
- Acronym / sponsor ID
- ATH-1017-PD-0201
- Keywords
- Parkinson's Disease Dementia, Dementia with Lewy Bodies, Dementia, HGF/MET, Hepatocyte Growth Factor, Neurotrophic, ATH-1017, Event-Related Potential
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment ended early due to study design limitations.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- LeonaBioIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety and treatment effects of fosgonimeton (ATH-1017) in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized treatment duration of 26 weeks.
Detailed description
The study is designed to evaluate the safety and treatment effects of ATH-1017 in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized, double-blind, placebo-controlled, parallel-arm treatment duration of 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 40mg Dose | Experimental | Drug: ATH-1017Daily subcutaneous injection of 40mg ATH-1017 |
| 70mg Dose | Experimental | Drug: ATH-1017Daily subcutaneous injection of 70mg ATH-1017 |
| Placebo | Placebo comparator | Drug: PlaceboDaily subcutaneous injection of Placebo |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATH-1017Daily subcutaneous injection of ATH-1017 in a pre-filled syringe | Drug | 40mg Dose, 70mg Dose |
| PlaceboDaily subcutaneous injection of Placebo in a pre-filled syringe | Drug | Placebo |
Primary outcome
Global Statistical Test (GST) Score at Baseline
Time frame: Baseline
The Global Statistical Test (GST) score is a composite of the change from baseline (CFB) z-scores to Week 26 in the Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13-Item Version (ADAS-Cog13; range 0-85; higher scores indicate greater impairment) and Event Related Potential P300 Latency (ERP P300; longer latency (milliseconds) indicates greater impairment). This composite approach was used to assess overall change in disease status and treatment effects of ATH-1017. The GST score was defined as a single outcome variable based on standardizing and combining individual patient-level z-score of change from baseline cognition (ADAS-Cog13) and ERP P300 latency scores. The between-group difference was calculated by subtracting the mean GST score for placebo from the mean GST score for ATH-1017. A negative value based on GST scores (ATH-1017 minus placebo) indicates a favorable response to ATH-1017, while a positive value favors placebo.
2 secondary outcomes
Event-related Potential (ERP) P300 Latency at Baseline
Time frame: Baseline
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Baseline
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATH-1017 in people with Parkinson Disease Dementia and Dementia With Lewy Bodies, run by LeonaBio at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Statistical Test (GST) Score at Baseline (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.