Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
Purpose
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.
Conditions
- Parkinson's Disease
- Multiple System Atrophy, Parkinson Variant
- Multiple System Atrophy
Eligibility
- Eligible Ages
- Between 35 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Early Parkinson's disease |
|
|
| Possible or Probable MSA-P |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Asklepios Biopharmaceutical, Inc.