Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy

AskBio Inc

Status: Active, not recruiting

Conditions: Multiple System Atrophy; Parkinson's Disease; Multiple System Atrophy, Parkinson Variant

Treatments: Other: This is an observational study.

Study type: Observational

Funder types: Industry

Identifiers

NCT05699460

ASK-PD-0-CS-001

Details and patient eligibility

About

The objective of this study is to describe disease progression in study participants diagnosed with early Parkinson's Disease or Multiple System Atrophy - Parkinsonian Type up to 18 months as delineated by clinical and biochemical parameters.

Enrollment: 150 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Idiopathic PD
• Diagnosis of MSA-P
• One to six years from clinical diagnosis of PD
• Less than 4 years from clinical diagnosis of MSA with expected survival >3 years
• Stable medication regimen
• Ability to walk with or without an assistive device

Exclusion criteria

• Movement disorder due to known cerebrovascular disease, brain tumor, trauma, exposure to parkinsonian-linked toxicants or other neurological diseases
• Presence of dementia, psychosis, substance abuse or poorly controlled depression
• Prior brain surgery (i.e. deep brain stimulation) or other brain imaging abnormalities
• History of cancer or poorly controlled medical conditions
• Receiving an investigational drug

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

150 participants in 2 patient groups

Early Parkinson's disease

Treatment:

Other: This is an observational study.

Possible or Probable MSA-P

Treatment:

Other: This is an observational study.