Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

423 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2024-10-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label extension

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage

Group Type EXPERIMENTAL

ATH-1017

Intervention Type DRUG

Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Interventions

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ATH-1017

Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No