ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease (LIFT-AD)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04488419 |
Recruitment Status :
Active, not recruiting
First Posted : July 28, 2020
Last Update Posted : January 31, 2024
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease Dementia of Alzheimer Type | Drug: ATH-1017 Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 554 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, double-blind, placebo-controlled, parallel-group study |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Mild to Moderate Alzheimer's Disease |
Actual Study Start Date : | September 28, 2020 |
Estimated Primary Completion Date : | July 2024 |
Estimated Study Completion Date : | August 2024 |
Arm | Intervention/treatment |
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Experimental: Dosage
Daily subcutaneous (SC) injection of 40mg ATH-1017
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Drug: ATH-1017
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe |
Placebo Comparator: Placebo
Daily subcutaneous (SC) injection of Placebo
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Drug: Placebo
Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe |
- To evaluate the clinical efficacy of ATH1017 in subjects not on background acetylcholinesterase inhibitors (AChEIs) [ Time Frame: Week 26 ]The Global Statistical Test (GST) score that combines the change from baseline scores from cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11]) and function (Alzheimer's Disease Cooperative Study-Activities of Daily Living, 23-item version [ADCS-ADL23] score)
- Cognition [ Time Frame: Week 26 ]Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11] (Range of 0 to 70, where 0 is least impairment and 70 is most severe impairment)
- Activities of Daily Living [ Time Frame: Week 26 ]Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version [ADCS-ADL23] (Range of 0 to 78, where a higher score indicates greater function)
- To determine the effect of ATH1017 on plasma neurofilament light chain (NfL) concentration [ Time Frame: Week 26 ]NfL concentration change from Baseline at Week 26
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Ages Eligible for Study: | 55 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key 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
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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
Key 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488419
Responsible Party: | Athira Pharma |
ClinicalTrials.gov Identifier: | NCT04488419 |
Other Study ID Numbers: |
ATH-1017-AD-0201 |
First Posted: | July 28, 2020 Key Record Dates |
Last Update Posted: | January 31, 2024 |
Last Verified: | January 2024 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer's Disease Cognition Dementia |
ATH-1017 LIFT AD Fosgonimeton |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |