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

ArmDescriptionAssigned Intervention
Early Parkinson's disease
  • Other: This is an observational study.
    This is an observational study.
Possible or Probable MSA-P
  • Other: This is an observational study.
    This is an observational study.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Chinemeihe Alaku
617-643-2862
calaku@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Asklepios Biopharmaceutical, Inc.

Study Contact

Amber Van Laar, M.D.
336-265-2790
askfirst@askbio.com