Synuclein-One Study

CND Life Sciences

Status: Completed

Conditions: Multiple System Atrophy; Parkinson Disease; Dementia With Lewy Bodies; Pure Autonomic Failure

Treatments: Diagnostic Test: Skin Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT04700722

CND-100

Details and patient eligibility

About

The Synuclein-One Study will be evaluating α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases.

Full description

Phosphorylated α-synuclein pathology in the diagnosis of synucleinopathies through qualitative and quantitative measurements of cutaneous phosphorylated α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. An effective tissue biomarker will provide an accurate diagnosis of α-synuclein in clinical practice, will differentiate between synucleinopathies, enable assessment of target engagement in the development of disease modifying and neuroprotective therapies and accelerate the development of neuroprotective and disease modifying therapies.

Enrollment: 428 patients

Sex: All

Ages: 40 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female between 40-99 years of age
• Prior clinical diagnosis of Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies or Pure Autonomic Failure
• Health Subjects, no history of clinical or symptoms suggestive with synucleinopathy

Exclusion criteria

• Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, vascular claudication)
• Clinically active coronary artery or cerebrovascular disease
• Current smoker or alcoholism
• History of allergic reaction to local anesthesia for skin biopsies
• Use of blood thinners (aspirin or Plavix alone is allowed)
• Significantly impaired wound healing or history of scarring or keloid formation
• Healthy individuals or individuals with synucleinopathy is disease may be explained by other causes: recent history of encephalitis, Cortical dementia of Alzheimer's type, Whipple's disease, toxin exposure, repeated head injury and stepwise disease progression suggestive of vascular etiology

Trial design

428 participants in 5 patient groups

Parkinson's disease

Description:

Looking for 105 patients with a clinically established diagnosis of Parkinson's disease between 40-99 years of age.

Treatment:

Diagnostic Test: Skin Biopsy

Multiple System Atrophy

Description:

Looking for 40 patients with a clinically established diagnosis of Multiple System Atrophy between 40-99 years of age.

Treatment:

Diagnostic Test: Skin Biopsy

Dementia with Lewy bodies

Description:

Looking for 95 patients with a clinically established diagnosis of Dementia with Lewy bodies between 40-99 years of age.

Treatment:

Diagnostic Test: Skin Biopsy

Pure Autonomic Failure

Description:

Looking for 60 patients with a clinically established diagnosis of Pure Autonomic Failure between 40-99 years of age.

Treatment:

Diagnostic Test: Skin Biopsy

Healthy Controls

Description:

No history of clinical or symptoms suggestive of Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies or Pure Autonomic Failure between 40-99 years of age.

Treatment:

Diagnostic Test: Skin Biopsy