Alzheimer Disease
Conditions
Keywords
Alzheimer's, Dementia, ATH-1017, Open Label
Brief summary
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.
Detailed description
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.
Interventions
DRUGATH-1017
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
Sponsors
Athira Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label extension
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subject has completed the Week 26 visit of either of the two blinded parent studies (ATH-1017-AD-0201 or ATH-1017-AD-0202). * Reliable and capable support person/caregiver who is willing to accept responsibility for supervising the daily treatment or, if required, administering study drug. * Subject capable of giving signed informed consent, or by a legally acceptable representative. * Subjects must be in generally good health. * Male subjects and their partners must agree to continue to use a double-barrier method of contraception during the study, including the follow-up period, unless the partner is not of childbearing potential.
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: * Adequately treated squamous and basal cell carcinoma, or squamous and basal cell carcinoma in situ * Prostate carcinoma in situ
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Up to 173 weeks (study termination) | 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 |
Countries
United States
Participant flow
Recruitment details
This study was conducted in the United States and Australia.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 423 |
| Total | 423 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | >1 reason | 20 |
| Overall Study | Adverse Event | 50 |
| Overall Study | Early study termination or other undetermined reasons | 224 |
| Overall Study | Lack of Efficacy | 31 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Nursing home replacement | 3 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Site closure | 4 |
| Overall Study | Withdrawal by Subject | 45 |
Baseline characteristics
| Characteristic | ATH-1017 40 Milligrams (mg) |
|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 7.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 384 Participants |
| Sex: Female, Male Female | 218 Participants |
| Sex: Female, Male Male | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 423 |
| other Total, other adverse events | 348 / 423 |
| serious Total, serious adverse events | 54 / 423 |
Outcome results
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
Time frame: Up to 173 weeks (study termination)
Population: Safety population: all participants who received at least one dose of study medication
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATH-1017 40 Milligrams (mg) | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | At least 1 TEAE | 323 Participants |
| ATH-1017 40 Milligrams (mg) | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | No TEAEs | 100 Participants |