NCT05479552 · ACTIVE NOT RECRUITING
A Diagnostic Test for Dementia With Lewy Bodies
This study is testing a diagnostic tool called the Syn-One Test, which looks for a protein called alpha-synuclein in a skin biopsy. The goal is to better distinguish between two conditions that are often confused: early Alzheimer's disease and Lewy body dementia. This is a diagnostic accuracy study, not a treatment trial, so no experimental drugs are involved.
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're excluded 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-01-15