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Trial record 1 of 1 for:    04700722
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Synuclein-One Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04700722
Recruitment Status : Active, not recruiting
First Posted : January 8, 2021
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
CND Life Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Parkinson Disease Multiple System Atrophy Dementia With Lewy Bodies Pure Autonomic Failure Diagnostic Test: Skin Biopsy

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cutaneous Phosphorlyated α-synuclein Detection as a Biomarker of Synucleinopathy
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : January 11, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Parkinson's disease
Looking for 105 patients with a clinically established diagnosis of Parkinson's disease between 40-99 years of age.
 Diagnostic Test: Skin Biopsy
Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Multiple System Atrophy
Looking for 40 patients with a clinically established diagnosis of Multiple System Atrophy between 40-99 years of age.
 Diagnostic Test: Skin Biopsy
Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Dementia with Lewy bodies
Looking for 95 patients with a clinically established diagnosis of Dementia with Lewy bodies between 40-99 years of age.
 Diagnostic Test: Skin Biopsy
Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Pure Autonomic Failure
Looking for 60 patients with a clinically established diagnosis of Pure Autonomic Failure between 40-99 years of age.
 Diagnostic Test: Skin Biopsy
Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
Healthy Controls
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.
 Diagnostic Test: Skin Biopsy
Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Outcome 1 [ Time Frame: 2 years ]
    To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein.

  2. Primary Outcome 2 [ Time Frame: 2 years ]
    To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein.

  3. Primary Outcome 3 [ Time Frame: 2 years ]
    To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.


Biospecimen Retention:   Samples Without DNA
Skin Biopsy

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Eligible men and women, age 40-99 years, will undergo a screening evaluation that includes a thorough medical history, physical and neurologic exam, orthostatic vitals, questionnaires and skin biopsy completed in one visit.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700722


Locations
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Sponsors and Collaborators
CND Life Sciences
Investigators
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Principal Investigator: Todd Levine, MD CND Life Sciences: www.cndlifesciences.com
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CND Life Sciences
ClinicalTrials.gov Identifier: NCT04700722    
Other Study ID Numbers: CND-100
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be shared with researchers that are involved in the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CND Life Sciences:
Neurodegenerative Diseases
Additional relevant MeSH terms:
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Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Lewy Body Disease
Pure Autonomic Failure
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
 Synucleinopathies
Neurodegenerative Diseases
Dementia
Neurocognitive Disorders
Mental Disorders
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases