Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
80 participants
OBSERVATIONAL
2022-08-15
2025-10-31
Brief Summary
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Synuclein-One Study
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Detailed Description
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Subjects enrolled in the study will have baseline evaluations and follow up visits at 12 months to define any changes to clinical diagnosis. Skin biopsies will be repeated at the 12 month follow up visit to determine the rate of P-SYN accumulation over time and rates of nerve fiber degeneration within punch skin biopsies.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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MCI-AD
Will be diagnosed using 'preclinical AD' criteria of mild cognitive impairment supported by a positive biomarker for AD. MCI defined as: 1. History of cognitive decline, noticed by either the patient, family member(s) or a medical practitioner but still independent in most complex daily activities. 2. Documentation of cognition not normal e.g., by MoCA or neuropsychological testing; 3. Does not meet the definition of dementia with MOCA \<18 or global CDR 1 or greater (although exceptions may exist with appropriate justification). 4. Supportive AD biomarker (has positive biomarkers for both Aβ and neuronal injury using CSF or neuroimaging).
Syn-One Test
CND Life Sciences is expanding the utility of its diagnostic technology, the Syn-One Test, to pathologically distinguish between early DLB and Alzheimer's disease to prevent misdiagnoses and establish the relationship between progression and α-synuclein deposition by measuring α- synuclein accumulation in patient's nerve fibers using a simple skin punch biopsy.
MCI-DLB
Will be diagnosed as prodromal probable MCI-DLB based on consensus criteria using 2 or more core clinical features of DLB (with or without the presence of biomarkers) or 1 or more core clinical features with 1 or more indicative biomarkers (reduced dopamine transporter uptake in basal ganglia demonstrated by SPECT or PET reduced Iodine-MIBG uptake on myocardial scintigraphy, PSG confirmation of REM without atonia).
Syn-One Test
CND Life Sciences is expanding the utility of its diagnostic technology, the Syn-One Test, to pathologically distinguish between early DLB and Alzheimer's disease to prevent misdiagnoses and establish the relationship between progression and α-synuclein deposition by measuring α- synuclein accumulation in patient's nerve fibers using a simple skin punch biopsy.
Interventions
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Syn-One Test
CND Life Sciences is expanding the utility of its diagnostic technology, the Syn-One Test, to pathologically distinguish between early DLB and Alzheimer's disease to prevent misdiagnoses and establish the relationship between progression and α-synuclein deposition by measuring α- synuclein accumulation in patient's nerve fibers using a simple skin punch biopsy.
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of mild cognitive impairment, and a presumed etiology of DLB or AD at enrollment
Exclusion Criteria
2. Clinically active coronary artery or cerebrovascular disease
3. Current smoker or alcoholism
4. History of allergic reaction to local anesthesia (for biopsy collection)
5. Use of anticoagulants (aspirin or Plavix alone is allowed)
6. Significantly impaired wound healing or history of scarring or keloid formation
50 Years
85 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
CND Life Sciences
OTHER
Responsible Party
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Principal Investigators
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Todd Levine, MD
Role: PRINCIPAL_INVESTIGATOR
CND Life Sciences
Locations
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CND Life Sciences
Scottsdale, Arizona, United States
University of California San Diego
La Jolla, California, United States
CenExel RMCR
Englewood, Colorado, United States
University of Miami
Boca Raton, Florida, United States
Neurology One
Winter Park, Florida, United States
Ochsner Research
New Orleans, Louisiana, United States
Mass General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Headlands Research
Plymouth, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Gibbons CH, Freeman R, Bellaire B, Adler CH, Moore D, Levine T. Synuclein-One study: skin biopsy detection of phosphorylated alpha-synuclein for diagnosis of synucleinopathies. Biomark Med. 2022 May;16(7):499-509. doi: 10.2217/bmm-2021-0646. Epub 2022 Mar 11.
Gibbons CH, Galasko D, Press D, Claassen D, Levine T, Freeman R. The Syn-D study: detection of cutaneous phosphorylated alpha-synuclein in mild cognitive impairment a trial protocol. Biomark Med. 2025 Jul;19(13):501-508. doi: 10.1080/17520363.2025.2520154. Epub 2025 Jun 16.
Other Identifiers
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101
Identifier Type: -
Identifier Source: org_study_id
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