Biomarker Study of ATH434 in Participants With MSA

Sponsor

Alterity Therapeutics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05732415

Collaborator

(none)

Enrollment

Location

Arm

20.5

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy

Condition or Disease	Intervention/Treatment	Phase
Multiple System Atrophy	Drug: ATH434	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Nov 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ATH434	Drug: ATH434 ATH434 taken BID

Arm

Intervention/Treatment

Experimental: ATH434

Drug: ATH434

ATH434 taken BID

Outcome Measures

Primary Outcome Measures

Change in iron content as measured by brain MRI [Change from Baseline to Week 52]

Secondary Outcome Measures

Change in Aggregating alpha-Synuclein Levels [Change from Baseline to Week 52]
Change in Neurofilament Light Chain Levels [Change from Baseline to Week 52]
Change in Unified MSA Rating Scale (UMSARS) Score [Change from Baseline to Week 52]
Change in SF-36 Score [Change from Baseline to Week 52]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participant has clinical features of parkinsonism.
Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
Participant has ataxia and/or pyramidal signs on neurological examination.
Participant has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion Criteria:

Participant is unable to swallow study drug.
Participant is unable to attend study visits or complete study procedures.
Participant has structural brain abnormality on MRI.
Participant has any significant neurological disorder other than MSA.
Participant has an unstable medical or psychiatric illness.
Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.