A Diagnostic Test for Dementia With Lewy Bodies

NCT05479552 | Active Not Recruiting

• 2 other identifiers: 101R44AG076072
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 12

Brief Summary

The Syn-D Study will be evaluating α-synuclein in patients with suspected MCI-AD and MCI-DLB. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases.

Conditions

MCI-AD, Early Stage Alzheimer's Disease; MCI-DLB, Early Stage Dementia With Lewy Bodies

Outcome Measures

Primary Outcomes (2)

• This is a prospective longitudinal study of individuals with neurodegenerative DLB and AD disorders to improve the diagnostic precision and utility of the Syn-One TestTM.

  To pathologically distinguish DLB from AD early in the course of the disease using the Syn-One TestTM, confirming disease diagnosis through prospective clinical assessments and follow up biopsy analyses over 12 months.

  2 years

• This is a prospective longitudinal study of individuals with neurodegenerative DLB and AD disorders to improve the diagnostic precision and utility of the Syn-One TestTM.

  To define the rates of neuronal degeneration in DLB through systematic pathological quantitation of skin biopsies measuring P-SYN deposition and cutaneous nerve fiber degeneration, compared to AD, and correlating pathological findings with clinical assessments over the course of 12 months.

  2 years

Secondary Outcomes (2)

• Secondary Aim 1

  2 years

• Secondary Aim 2

  2 years

Study Arms (2)

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).

Diagnostic Test: Syn-One Test

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).

Diagnostic Test: Syn-One Test

Interventions

Syn-One Test DIAGNOSTIC_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-AD; MCI-DLB

Eligibility Criteria

• Age: 50 Years - 85 Years
• Gender Eligibility Details: Sex is determined by gender at birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects evaluated in the protocol will have a diagnosis of mild dementia with Lewy bodies (MCI-DLB) or mild Alzheimer's disease (MCI-AD). Patients will be evaluated at Baseline and 12 months. A total of 80 individuals will be enrolled, 40 with MCI-DLB and 40 with MCD-AD, with roughly equal representation of men and women. All subjects will undergo screening evaluation that includes a thorough medical history, physical and neurologic examination and review of available medical records, laboratory studies, neuroimaging and sleep laboratory studies.

You may qualify if:

• Men and women 50 to 85 years of age
• Clinical diagnosis of mild cognitive impairment, and a presumed etiology of DLB or AD at enrollment

You may not qualify if:

• Clinical evidence of severe peripheral vascular disease (Fazekas score of ≥ 3, or a large vessel stroke of ≥ 2 cm, 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 biopsy collection)
• Use of anticoagulants (aspirin or Plavix alone is allowed)
• Significantly impaired wound healing or history of scarring or keloid formation

Sponsors & Collaborators

• CND Life Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (12)

CND Life Sciences

Scottsdale, Arizona, 85258, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

CenExel RMCR

Englewood, Colorado, 80113, United States

Location

University of Miami

Boca Raton, Florida, 33433, United States

Location

Neurology One

Winter Park, Florida, 32792, United States

Location

Ochsner Research

New Orleans, Louisiana, 70121, United States

Location

Mass General Hospital

Boston, Massachusetts, 02145, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Headlands Research

Plymouth, Massachusetts, 02360, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37240, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (2)

• 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.

  PMID: 35272481 BACKGROUND

• 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.

  PMID: 40523872 DERIVED

Study Officials

• Todd Levine, MD

  CND Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 29, 2022
• Study Start: August 15, 2022
• Primary Completion: September 28, 2025
• Study Completion: October 31, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)