A Phase 2 interventional study of ATH-1017 and Placebo in Alzheimer Disease and Dementia of Alzheimer Type, sponsored by Athira Pharma. Completed at 13 sites in 2 countries. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Athira Pharma · Phase 2, 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 781st largest by enrollment of the 1,608 interventional ones that give a count, is one of 104 that started in 2020, is one of 360 in phase 2, and was the 1,222nd 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. 104 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 77 is close to 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.
This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.
This study is designed to assess the correlation of the functional translational biomarker P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized, double-blind treatment.
Key Inclusion Criteria:
Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:
Key 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.
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.
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.
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.
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 (SC) injection of Low Dose ATH-1017
Drug: ATH-1017
Daily subcutaneous (SC) injection of High Dose ATH-1017
Drug: ATH-1017
Daily subcutaneous (SC) injection of Placebo
Drug: Placebo
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
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. Baseline was defined as Day 1.
Time frame: At Baseline (Day 1)
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. It was performed to evaluate the correlation of ERP P300 latency and cognition. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. Baseline was defined as Day 1.
Time frame: At Baseline (Day 1)
The study was conducted at a total of 6 centers in Australia and 8 centers in the United States (US).
| Milestone | Placebo | ATH-1017 40 Milligrams (mg) | ATH-1017 70 mg |
|---|---|---|---|
| Started | 24 | 27 | 26 |
| Completed | 23 | 24 | 19 |
| Not completed | 1 | 3 | 7 |
| Withdrew: Adverse event | 0 | 3 | 5 |
| Withdrew: Withdrawal by subject | 1 | 0 | 2 |
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. Baseline was defined as Day 1.
| Milliseconds (ms) | Placebo | ATH-1017 40 mg | ATH-1017 70 mg |
|---|---|---|---|
| Event-related Potential (ERP) P300 Latency at Baseline | 361.5 ± 32.23 | 382.3 ± 40.18 | 375.3 ± 35.77 |
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. It was performed to evaluate the correlation of ERP P300 latency and cognition. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. Baseline was defined as Day 1.
| Scores on a scale | Placebo | ATH-1017 40 mg | ATH-1017 70 mg |
|---|---|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline | 23.0 ± 7.96 | 22.4 ± 8.94 | 20.7 ± 7.18 |
Collected over Up to Week 30. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/24 (0%) | 0/24 (0%) | 18/24 (75%) |
| ATH-1017 40 mg | 0/27 (0%) | 3/27 (11.1%) | 24/27 (88.9%) |
| ATH-1017 70 mg | 0/26 (0%) | 0/26 (0%) | 26/26 (100%) |
| Event | Placebo | ATH-1017 40 mg | ATH-1017 70 mg |
|---|---|---|---|
| VertigoEar and labyrinth disorders | 0/24 | 1/27 | 0/26 |
| Hip fractureInjury, poisoning and procedural complications | 0/24 | 1/27 | 0/26 |
| Cholinergic syndromeNervous system disorders | 0/24 | 1/27 | 0/26 |
| Event | Placebo | ATH-1017 40 mg | ATH-1017 70 mg |
|---|---|---|---|
| Injection site reactionGeneral disorders | 1/24 | 17/27 | 21/26 |
| EosinophiliaBlood and lymphatic system disorders | 1/24 | 6/27 | 5/26 |
| Injection site vesiclesGeneral disorders | 0/24 | 4/27 | 1/26 |
| FatigueGeneral disorders | 0/24 | 4/27 | 1/26 |
| HeadacheNervous system disorders | 1/24 | 4/27 | 2/26 |
| PruritusSkin and subcutaneous tissue disorders | 1/24 | 4/27 | 1/26 |
| Injection site noduleGeneral disorders | 0/24 | 0/27 | 3/26 |
| DizzinessNervous system disorders | 2/24 | 2/27 | 3/26 |
| DiarrhoeaGastrointestinal disorders | 0/24 | 1/27 | 3/26 |
| Injection site painGeneral disorders | 0/24 | 3/27 | 1/26 |
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 | 70.0 ± 8.03 | 70.6 ± 6.54 | 73.4 ± 7.26 | 71.4 ± 7.32 |
| Sex: Female, Male(Participants) | Placebo | ATH-1017 40 mg | ATH-1017 70 mg | Total |
|---|---|---|---|---|
| Female | 12 | 15 | 12 | 39 |
| Male | 12 | 12 | 14 | 38 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | ATH-1017 40 mg | ATH-1017 70 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 0 | 3 |
| Not Hispanic or Latino | 21 | 27 | 26 | 74 |
| 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 | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 1 | 4 |
| White | 22 | 25 | 24 | 71 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2020 to primary completion in May 2022, 17 months.
Results were first posted in Jun 2023, 1 year after primary completion.
Of 130 industry-sponsored phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's 17 months is below that.
Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. 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