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Enrollment ended early due to study design limitations.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40mg Dose | Experimental | Daily subcutaneous injection of 40mg ATH-1017 |
|
| 70mg Dose | Experimental | Daily subcutaneous injection of 70mg ATH-1017 |
|
| Placebo | Placebo Comparator | Daily subcutaneous injection of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATH-1017 | Drug | Daily subcutaneous injection of ATH-1017 in a pre-filled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States | ||
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This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study comparing ATH-1017 40 milligrams per day (mg/day) and ATH-1017 70 mg/day with placebo in participants with Parkinson's Disease Dementia or Dementia with Lewy Bodies.
The study was conducted at a total of 7 centers in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2021 | Jan 9, 2025 |
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| Placebo | Drug | Daily subcutaneous injection of Placebo in a pre-filled syringe |
|
| 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. | Baseline |
| Premiere Research Institute |
| West Palm Beach |
| Florida |
| 33407 |
| United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| QUEST Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Center for Cognitive Health | Portland | Oregon | 97225 | United States |
| Keystone Clinical Studies LLC | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Evergreen Health Research | Kirkland | Washington | 98034 | United States |
| Inland Northwest Research LLC | Spokane | Washington | 99202 | United States |
| FG001 | ATH-1017 40 Milligrams (mg) | Participants were randomized to receive ATH-1017 40mg via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| FG002 | ATH-1017 70 mg | Participants were randomized to receive ATH-1017 70mg via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety Population: included all randomized participants who received at least one dose of the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| BG001 | ATH-1017 40 mg | Participants were randomized to receive ATH-1017 40 mg via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| BG002 | ATH-1017 70 mg | Participants were randomized to receive ATH-1017 70 mg via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified intent to treat population. | Posted | Mean | Standard Deviation | Z-score | Baseline |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Modified intent to treat population. | Posted | Mean | Standard Deviation | Millisecond (ms) | Baseline |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Modified intent to treat population. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 | 0 | 9 | 1 | 9 | 7 | 9 |
| EG001 | ATH-1017 40 Milligrams (mg) | Participants were randomized to receive ATH-1017 40mg via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 | 0 | 9 | 1 | 9 | 9 | 9 |
| EG002 | ATH-1017 70 mg | Participants were randomized to receive ATH-1017 70mg via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 | 1 | 10 | 1 | 10 | 9 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Psychotic symptom | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Injection site hypersensitivity | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Herpes pharyngitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Freezing phenomenon | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Psychotic symptom | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
This study was stopped early prior to the accrual of the planned sample size of approximately 75 evaluable participants.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Javier San Martin, CMO | Athira Pharma | 1-866-725-0930 | clinicaltrials@athira.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2023 | Jan 9, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| D003704 | Dementia |
| C564265 | Deafness, Autosomal Recessive 39 |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | ATH-1017 70 mg | Participants were randomized to receive ATH-1017 70mg via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
|
|
| OG002 | ATH-1017 70 mg | Participants were randomized to receive ATH-1017 70mg via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
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