A Diagnostic Test for Dementia With Lewy Bodies

Recruiting

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

• Registration Number: NCT05479552
• Lead Sponsor: CND Life Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-7-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Men and women 50 to 85 years of age<br><br> 2. Clinical diagnosis of mild cognitive impairment, and a presumed etiology of DLB or<br> AD at enrollment<br><br>Exclusion Criteria:<br><br> 1. Clinical evidence of severe peripheral vascular disease (Fazekas score of = 3, or a<br> large vessel stroke of = 2 cm, history of ulceration, poor wound healing, vascular<br> claudication)<br><br> 2. Clinically active coronary artery or cerebrovascular disease<br><br> 3. Current smoker or alcoholism<br><br> 4. History of allergic reaction to local anesthesia (for biopsy collection)<br><br> 5. Use of anticoagulants (aspirin or Plavix alone is allowed)<br><br> 6. Significantly impaired wound healing or history of scarring or keloid formation

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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.

Secondary Outcome Measures

Name	Time	Method
Secondary Aim 1;Secondary Aim 2