A Phase 2 interventional study of ATH-1017 and Placebo in Parkinson Disease Dementia and Dementia With Lewy Bodies, sponsored by Athira Pharma. Terminated at 10 sites in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Athira Pharma · Phase 2, Interventional, and Treatment
Among 110 studies in Lewy Body Disease with a site in United States — 32 open to participants now, 40 under way, 1 of them phase 3. Lewy Body Disease · United States.
Among the 110 studies in Lewy Body Disease with a site in United States, this one is the 63rd largest by enrollment of the 78 interventional ones that give a count, is one of 9 that started in 2022, is one of 21 in phase 2, and was the 64th registered.
239 studies on the registry are indexed under Lewy Body Disease; 89 are open to participants now.
Browse Lewy Body Disease studies →32 of the 110 studies in Lewy Body Disease with a site in United States are open now. Recruiting first, the newest first:
University of Washington · Sites in United States
Ages 18+
NYU Langone Health · Sites in United States
Ages 18–90 · Healthy volunteers
Eli Lilly and Company · Sites in United States, Japan, Korea, Republic of and 1 more country
Ages 55–85
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Sites in United States
Ages 18+
University of Pennsylvania · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 63 Lewy Body Disease studies recruiting now, 41 (65%) set no upper age limit and none (0%) stop at 75 or younger; 10 take children under 18; 31 take healthy volunteers.
This study: 40 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
110 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 24 · Phase 3 4 · Phase 4 8
First in 2002; this study’s year is marked. 9 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 28 is below the median of 89 across 152 interventional studies indexed under Lewy Body Disease.
Median enrollment 86 across the 78 interventional studies, 225 across the 31 observational. Of the 66 that completed or were terminated, 33 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 110 have an industry lead sponsor. The 10 most frequent:
Athira Pharma is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Athira Pharma has 1 study filed under Lewy Body Disease — fewer than ten, so there is no comparison to draw.
13 of the studies in Lewy Body Disease with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06098612Massachusetts General HospitalPET Imaging Evaluation of [11C]SY08 | 2026-11 |
| NCT01799915NYU Langone HealthNatural History Study of Synucleinopathies | 2026-12-30 |
| NCT03233646Duke UniversityRetinal Imaging in Neurodegenerative Disease | 2026-12-31 |
| NCT03702907Georgetown UniversityDC Longitudinal Study on Aging and Specimen Bank | 2027-01 |
| NCT04246437Daniel Claassen[18F]F-DOPA Imaging in Patients With Autonomic Failure | 2027-02-01 |
Add all 13 to your calendar (.ics) → With an account.
Among the 110 studies in Lewy Body Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily subcutaneous injection of 40mg ATH-1017
Drug: ATH-1017
Daily subcutaneous injection of 70mg ATH-1017
Drug: ATH-1017
Daily subcutaneous injection of Placebo
Drug: Placebo
Daily subcutaneous injection of ATH-1017 in a pre-filled syringe
Daily subcutaneous injection of Placebo in a pre-filled syringe
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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: Baseline
The study was conducted at a total of 7 centers in the United States (US).
| Milestone | Placebo | ATH-1017 40 Milligrams (mg) | ATH-1017 70 mg |
|---|---|---|---|
| Started | 9 | 9 | 10 |
| Completed | 7 | 7 | 5 |
| Not completed | 2 | 2 | 5 |
| Withdrew: Adverse event | 1 | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 1 | 2 |
| Withdrew: Undetermined | 1 | 1 | 0 |
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.
| Z-score | Placebo | ATH-1017 40 mg | ATH-1017 70 mg |
|---|---|---|---|
| Global Statistical Test (GST) Score at Baseline | -0.222 ± 0.6365 | 0.332 ± 0.6337 | -0.036 ± 1.0050 |
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.
| Millisecond (ms) | Placebo | ATH-1017 40 Milligrams (mg) | ATH-1017 70 mg |
|---|---|---|---|
| Event-related Potential (ERP) P300 Latency at Baseline | 381.84 ± 51.739 | 373.19 ± 18.669 | 367.84 ± 45.635 |
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.
| score on a scale | Placebo | ATH-1017 40 Milligrams (mg) | ATH-1017 70 mg |
|---|---|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Baseline | 16.9 ± 6.94 | 29.7 ± 10.03 | 23.8 ± 11.49 |
Collected over Up to Week 30. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/9 (0%) | 1/9 (11.1%) | 7/9 (77.8%) |
| ATH-1017 40 Milligrams (mg) | 0/9 (0%) | 1/9 (11.1%) | 9/9 (100%) |
| ATH-1017 70 mg | 1/10 (10%) | 1/10 (10%) | 9/10 (90%) |
| Event | Placebo | ATH-1017 40 Milligrams (mg) | ATH-1017 70 mg |
|---|---|---|---|
| Femoral neck fractureInjury, poisoning and procedural complications | 1/9 | 0/9 | 0/10 |
| Psychotic symptomPsychiatric disorders | 0/9 | 1/9 | 0/10 |
| Subarachnoid haemorrhageNervous system disorders | 0/9 | 0/9 | 1/10 |
| Event | Placebo | ATH-1017 40 Milligrams (mg) | ATH-1017 70 mg |
|---|---|---|---|
| Injection site reactionGeneral disorders | 0/9 | 2/9 | 4/10 |
| FallInjury, poisoning and procedural complications | 3/9 | 2/9 | 4/10 |
| Injection site noduleGeneral disorders | 0/9 | 3/9 | 2/10 |
| Urinary tract infectionInfections and infestations | 1/9 | 2/9 | 1/10 |
| Injection site painGeneral disorders | 0/9 | 1/9 | 2/10 |
| AnaemiaBlood and lymphatic system disorders | 1/9 | 0/9 | 0/10 |
| TinnitusEar and labyrinth disorders | 0/9 | 1/9 | 0/10 |
| DiarrhoeaGastrointestinal disorders | 1/9 | 0/9 | 0/10 |
| DysphagiaGastrointestinal disorders | 0/9 | 1/9 | 0/10 |
| Intestinal obstructionGastrointestinal disorders | 1/9 | 0/9 | 0/10 |
Safety Population: included all randomized participants who received at least one dose of the study medication.
| Age, Continuous(years) | Placebo | ATH-1017 40 mg | ATH-1017 70 mg | Total |
|---|---|---|---|---|
| Mean | 74.9 ± 4.86 | 70.7 ± 9.89 | 74.2 ± 7.5 | 73.3 ± 7.62 |
| Sex: Female, Male(Participants) | Placebo | ATH-1017 40 mg | ATH-1017 70 mg | Total |
|---|---|---|---|---|
| Female | 4 | 1 | 2 | 7 |
| Male | 5 | 8 | 8 | 21 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | ATH-1017 40 mg | ATH-1017 70 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 9 | 9 | 9 | 27 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | ATH-1017 40 mg | ATH-1017 70 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 8 | 9 | 10 | 27 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2022 to primary completion in Apr 2023, 14 months.
Results were first posted in Mar 2025, 1 year 10 months after primary completion. A results delay was requested in Apr 2024.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fosgonimeton sodium
Athira Pharma