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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-28

Study Completion Date

2024-07-15

Brief Summary

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This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.

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Detailed Description

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The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with randomized, parallel-arm treatment duration of 26 weeks, and based on clinical diagnostic criteria of Alzheimer's disease. Clinical efficacy is demonstrated by improvement in cognition and global/functional assessments comparing treatment to placebo.

Conditions

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Alzheimer Disease Dementia of Alzheimer Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled, parallel-group study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dosage

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

Group Type EXPERIMENTAL

ATH-1017

Intervention Type DRUG

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

Placebo

Daily subcutaneous (SC) injection of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily subcutaneous (SC) injection of Placebo 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

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 55 to 85 years
* Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
* Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
* Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m2 at Screening
* Reliable and capable support person/caregiver
* Treatment-free (subjects not receiving acetylcholinesterase inhibitor \[AChEI\] treatment), defined as:

* Treatment-naïve, OR
* Subjects who received an AChEI in the past and discontinued at least 4 weeks prior to Screening

Exclusion Criteria

* History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
* Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD
* History of brain MRI scan indicative of any other significant abnormality
* Diagnosis of severe major depressive disorder even without psychotic features.
* Significant suicide risk
* History within 2 years of Screening, or current diagnosis of psychosis
* Myocardial infarction or unstable angina within the last 6 months
* Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
* Subject has either hypertension or symptomatic hypotension
* Clinically significant ECG abnormality at Screening
* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<45 mL/min
* Hepatic impairment with alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of normal, or Child-Pugh class B and C
* Malignant tumor within 3 years before Screening
* Memantine in any form, combination or dosage within 4 weeks prior to Screening
* Acetylcholinesterase inhibitors in any dosage form
* The subject has received active amyloid or tau immunization (i.e., vaccination for Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for Alzheimer's disease) within 6 months of Screening

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No