Not provided
Not provided
Not provided
Not provided
Not provided
ATH-1017-AD-0203 was terminated after the Ph2/3 parent trial (LIFT-AD; NCT04488419) did not meet its primary endpoint, the GST score.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to determine the safety and tolerability of fosgonimeton (ATH-1017) in subjects with mild to moderate Alzheimer's disease who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202.
This is a multicenter, seamless, open-label extension (OLEX) study of ATH-1017 treatment in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease who completed 26 weeks treatment in the randomized, placebo-controlled, double-blind studies, ATH-1017-AD-0201 and ATH-1017-AD-0202. This OLEX study will provide additional, longer-term safety and tolerability information on ATH-1017 administration up to 48 months in subjects with mild to moderate Alzheimer's disease.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATH-1017 | Drug | Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Description - To determine the safety and tolerability of ATH-1017 in subjects with mild to moderate Alzheimer's disease (AD) who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202 | Up to 173 weeks (study termination) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject has experienced a serious adverse event during the parent study, which could present an increased safety risk during the open label extension.
New diagnosis of severe major depressive disorder even without psychotic features.
Any subject with formalized delusions or hallucinations.
Significant suicide risk.
Newly-diagnosed malignant tumor, except for the following conditions that are stable in the judgement of the investigator:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester-AD-CARE Program | Rochester | New York | 14620 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38599894 | Derived | Reda SM, Setti SE, Berthiaume AA, Wu W, Taylor RW, Johnston JL, Stein LR, Moebius HJ, Church KJ. Fosgonimeton attenuates amyloid-beta toxicity in preclinical models of Alzheimer's disease. Neurotherapeutics. 2024 Jul;21(4):e00350. doi: 10.1016/j.neurot.2024.e00350. Epub 2024 Apr 9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This was a multicenter, open label extension (OLEX) study of ATH-1017 treatment in participants with mild to moderate Alzheimer's disease (AD) who completed 26 weeks of treatment in the randomized, placebo-controlled, double-blind studies (ATH-1017-AD-0201; LIFT-AD or ATH-1017-AD-0202; ACT-AD).
This study was conducted in the United States and Australia.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ATH-1017 40 Milligrams (mg) | Participants administered ATH-1017 40 mg via subcutaneous (SC) injection (1 mL pre-filled syringe) once-daily (QD). Participants entering ATH-1017-AD-0203 on protocol versions prior to V4 were initially administered ATH-1017 70 mg via subcutaneous (SC) injection (1 mL pre-filled syringe) once-daily (QD). Data are reported for the overall safety population, including those who were previously treated with ATH-1017 70 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ATH-1017 40 Milligrams (mg) | Participants administered ATH-1017 40 mg via subcutaneous (SC) injection (1 mL pre-filled syringe) once-daily (QD). Participants entering ATH-1017-AD-0203 on protocol versions prior to V4 were initially administered ATH-1017 70 mg via subcutaneous (SC) injection (1 mL pre-filled syringe) once-daily (QD). Data are reported for the overall safety population, including those who were previously treated with ATH-1017 70 mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Description - To determine the safety and tolerability of ATH-1017 in subjects with mild to moderate Alzheimer's disease (AD) who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202 | Safety population: all participants who received at least one dose of study medication | Posted | Count of Participants | Participants | Up to 173 weeks (study termination) |
|
Up to 173 weeks; the protocolled 206-week treatment duration ended early due to study termination.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ATH-1017 40 Milligrams (mg) | Participants administered ATH-1017 40 mg via subcutaneous (SC) injection (1 mL pre-filled syringe) once-daily (QD). Participants entering ATH-1017-AD-0203 on protocol versions prior to V4 were initially administered ATH-1017 70 mg via subcutaneous (SC) injection (1 mL pre-filled syringe) once-daily (QD). Data are reported for the overall safety population, including those who were previously treated with ATH-1017 70 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reactions | General disorders | MedDRA (24.0) | Systematic Assessment | (high-level term) |
The study was terminated early, following the completion of the parent study (ATH-1017-AD-0201; LIFT-AD)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Javier San Martin, CMO | Athira Pharma | 1-866-725-0930 | clinicaltrials@athira.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2024 | Feb 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2024 | Feb 18, 2025 | SAP_001.pdf |
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
Not provided
Not provided
Open label extension
Not provided
Not provided
Not provided
Not provided
| Physician Decision |
|
| Protocol Violation |
|
| Site closure |
|
| Nursing home replacement |
|
| Lost to Follow-up |
|
| Early study termination or other undetermined reasons |
|
| >1 reason |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 4 |
| 423 |
| 54 |
| 423 |
| 348 |
| 423 |
| Monoclonal B-cell lymphocytosis | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Early onset familial Alzheimer's disease | Congenital, familial and genetic disorders | MedDRA (24.0) | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Oesophageal food impaction | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Acute psychosis | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
|
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
|
Not provided
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |