A Phase 2/3 interventional study of ATH-1017 in Alzheimer Disease, sponsored by Athira Pharma. Terminated at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Athira Pharma · Phase 2/3, Interventional, and Treatment
Among 1,939 studies in Alzheimer Disease with a site in United States — 345 open to participants now, 445 under way, 40 of them phase 3. Alzheimer Disease · United States.
Among the 1,939 studies in Alzheimer Disease with a site in United States, this one is the 218th largest by enrollment of the 1,608 interventional ones that give a count, is one of 145 that started in 2021, is one of 42 in phase 2/3, and was the 1,326th registered.
3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →345 of the 1,939 studies in Alzheimer Disease with a site in United States are open now. Recruiting first, the newest first:
National Institute on Aging (NIA) · Sites in United States
Ages 55–110 · Healthy volunteers
National Institute on Aging (NIA) · Sites in United States
Ages 65–120 · Healthy volunteers
Prevention Research Consortium Corp. · Sites in United States
Ages 55+ · Healthy volunteers
Hoffmann-La Roche · Sites in United States, Australia, France
Ages 50–90
University of Wisconsin, Madison · Sites in United States
Ages 60+ · 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 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.
This study: 55 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.
1,939 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 1 371 · Phase 2 469 · Phase 3 230 · Phase 4 60
First in 1981; this study’s year is marked. 145 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 423 is above the median of 70 across 3,020 interventional studies indexed under Alzheimer Disease.
Median enrollment 73 across the 1,608 interventional studies, 160 across the 309 observational. Of the 1,377 that completed or were terminated, 590 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
731 of 1,939 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 4 studies filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
164 of the studies in Alzheimer Disease with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT06126224Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | 2026-12-09 |
| NCT03860857Phase 3University of California, IrvineBiomarker Exploration in Aging, Cognition and Neurodegeneration | 2026-12-22 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT05980949Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyOpen-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) | 2027-09-07 |
Add all 164 to your calendar (.ics) → With an account.
Among the 1,939 studies in Alzheimer 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.
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.
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:
Newly-diagnosed malignant tumor, except for the following conditions that are stable in the judgement of the investigator:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage
Drug: ATH-1017
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
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
Time frame: Up to 173 weeks (study termination)
This study was conducted in the United States and Australia.
| Milestone | ATH-1017 40 Milligrams (mg) |
|---|---|
| Started | 423 |
| Completed | 35 |
| Not completed | 388 |
| Withdrew: Adverse event | 50 |
| Withdrew: Lack of efficacy | 31 |
| Withdrew: Withdrawal by subject | 45 |
| Withdrew: Physician decision | 3 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Site closure | 4 |
| Withdrew: Nursing home replacement | 3 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Early study termination or other undetermined reasons | 224 |
| Withdrew: >1 reason | 20 |
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
| Participants | ATH-1017 40 Milligrams (mg) |
|---|---|
| At least 1 TEAE | 323 |
| No TEAEs | 100 |
Collected over Up to 173 weeks; the protocolled 206-week treatment duration ended early due to study termination.. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ATH-1017 40 Milligrams (mg) | 4/423 (0.9%) | 54/423 (12.8%) | 348/423 (82.3%) |
| Event | ATH-1017 40 Milligrams (mg) |
|---|---|
| COVID-19Infections and infestations | 4/423 |
| PneumoniaInfections and infestations | 4/423 |
| Urinary tract infectionInfections and infestations | 4/423 |
| FallInjury, poisoning and procedural complications | 3/423 |
| SeizureNervous system disorders | 3/423 |
| Atrial fibrillationCardiac disorders | 2/423 |
| Respiratory syncytial virus infectionInfections and infestations | 2/423 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/423 |
| Metabolic encephalopathyNervous system disorders | 2/423 |
| AnaemiaBlood and lymphatic system disorders | 1/423 |
| Event | ATH-1017 40 Milligrams (mg) |
|---|---|
| Injection site reactionsGeneral disorders | 213/423 |
| COVID-19Infections and infestations | 44/423 |
| Urinary tract infectionInfections and infestations | 28/423 |
| FallInjury, poisoning and procedural complications | 24/423 |
| EosinophiliaBlood and lymphatic system disorders | 20/423 |
| Upper respiratory tract infectionInfections and infestations | 19/423 |
| Age, Continuous(years) | ATH-1017 40 Milligrams (mg) |
|---|---|
| Mean | 72.5 ± 7.34 |
| Sex: Female, Male(Participants) | ATH-1017 40 Milligrams (mg) |
|---|---|
| Female | 218 |
| Male | 205 |
| Race (NIH/OMB)(Participants) | ATH-1017 40 Milligrams (mg) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 14 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 17 |
| White | 384 |
| More than one race | 0 |
| Unknown or Not Reported | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2021 to primary completion in Oct 2024, 39 months.
Results were first posted in Apr 2025, 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 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