NCT05479552

A Diagnostic Test for Dementia With Lewy Bodies

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: CND Life Sciences · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In collaboration with approximately 10 centers that specialize in DLB and dementia we will recruit a total of 80 individuals for the study: 40 subjects with suspected MCI-DLB and 40 with suspected MCI-AD will be recruited. All subjects will be enrolled into a 12 month longitudinal study where skin biopsies will be performed at 3 sites on each patients at 12 month intervals (baseline and 1 year). Detailed quantified examination, cognitive evaluation, history, and questionnaires will be performed at each visit and will be reviewed by a central panel of disease experts to confirm the diagnosis. 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

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2022-08-15
• Primary completion: 2025-09-28
• Completion: 2025-10-31
• First posted: 2022-07-29
• Last updated: 2025-01-15

Locations

12 sites across 1 country: United States