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

Sponsor
Athira Pharma (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04886063
Collaborator
(none)
300
Enrollment
36
Locations
1
Arm
22
Anticipated Duration (Months)
8.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 one year in total in subjects with mild to moderate Alzheimer's disease.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open label extensionOpen label extension
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease
Actual Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Daily subcutaneous (SC) injection of ATH-1017

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Up to 26 Weeks]

    Safety and tolerability of ATH-1017 as measured by clinical laboratory measures, vital signs, and physical and neurological exams.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banner Sun Health Research Institute Sun City Arizona United States 85351
2 ATP Clinical Research, Inc Costa Mesa California United States 92626
3 Mile High Research Center Denver Colorado United States 80218
4 JEM Research Institute Lake Worth Florida United States 33462
5 Premiere Research Institute West Palm Beach Florida United States 33407
6 iResearch Atlanta, LLC Decatur Georgia United States 30030
7 iResearch Savannah Savannah Georgia United States 31405
8 Rush Alzheimer's Disease Center, Rush University Medical Center Chicago Illinois United States 60612
9 SIU Medicine Neuroscience Institute (NSI) Springfield Illinois United States 62702
10 IU Health Neuroscience Center Indianapolis Indiana United States 46202
11 Activmed Practices & Research, Inc. Lowell Massachusetts United States 01852
12 Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas Nevada United States 89106
13 Hackensack Meridian Hackensack University Medical Center Hackensack New Jersey United States 07601
14 Global Medical Institutes LLC; Princeton Medical Institute Princeton New Jersey United States 08540
15 Albuquerque Neuroscience Inc. Albuquerque New Mexico United States 87109
16 Neurological Associates of Albany Albany New York United States 12208
17 Manhattan Behavioral Medicine, LLC New York New York United States 10036
18 University of Rochester-AD-CARE Program Rochester New York United States 14620
19 Duke Neurology Research Durham North Carolina United States 27705
20 AMC Research, LLC Matthews North Carolina United States 28105
21 Neurology Diagnostics Dayton Ohio United States 45459
22 Neurobehavioral Clinical Research North Canton Ohio United States 44720
23 Summit Research Network Inc. Portland Oregon United States 97210
24 Center for Cognitive Health Portland Oregon United States 97225
25 Keystone Clinical Studies Norristown Pennsylvania United States 19462
26 Rhode Island Mood & Memory Research Institute East Providence Rhode Island United States 02914
27 Neurology Clinical, P.C. Cordova Tennessee United States 38018
28 Senior Adults Specialty Research Austin Texas United States 98757
29 Grayline Research Center Wichita Falls Texas United States 76309
30 University of Utah, Department of Neurology - Alzheimer's Disease Research Salt Lake City Utah United States 84108
31 University of Washington Seattle Washington United States 98104
32 St Vincent's Centre for Applied Medical Research, Translational Research Centre Darlinghurst New South Wales Australia 2010
33 Hammondcare Greenwich Hospital Greenwich New South Wales Australia 2065
34 KaRa MINDS Macquarie Park New South Wales Australia 2113
35 HammondCare Malvern Victoria Australia 3144
36 Australian Alzheimer's Research Organization Nedlands Western Australia Australia 6009

Sponsors and Collaborators

  • Athira Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Athira Pharma
ClinicalTrials.gov Identifier:
NCT04886063
Other Study ID Numbers:
  • ATH-1017-AD-0203
First Posted:
May 13, 2021
Last Update Posted:
Mar 14, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Athira Pharma
Alzheimer's
Dementia
ATH-1017
Open Label
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Mar 14, 2022