Summary

Eligibility
for people ages 50-85 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by David Coughlin, MD
Headshot of David Coughlin
David Coughlin

Description

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.

Details

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.

Keywords

MCI-AD, Early Stage Alzheimer's Disease, MCI-DLB, Early Stage Dementia With Lewy Bodies, Alzheimer Disease, Dementia, Lewy Body Disease, Syn-One Test, MCI-AD, MCI-DLB

Eligibility

You can join if…

Open to people ages 50-85

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

You CAN'T join if...

  1. 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)
  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

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States
  • CND Life Sciences accepting new patients
    Scottsdale Arizona 85258 United States

Lead Scientist at UCSD

  • David Coughlin, MD
    Movement disorders neurologist and clinician scientist with emerging research program in translational neuropathology. Using immunohistochemistry and image analysis techniques to better understand patterns pathology in neurodegenerative diseases and supporting in vivo biomarker development by advancing biomarker-pathological studies.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CND Life Sciences
ID
NCT05479552
Study Type
Observational
Participants
Expecting 80 study participants
Last Updated