A Diagnostic Test for Dementia With Lewy Bodies

Last updated: January 13, 2025
Sponsor: CND Life Sciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dementia

Lewy Body Dementia

Parkinson's Disease

Treatment

Syn-One Test

Clinical Study ID

NCT05479552
101
R44AG076072
  • Ages 50-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women 50 to 85 years of age

  2. Clinical diagnosis of mild cognitive impairment, and a presumed etiology of DLB orAD at enrollment

Exclusion

Exclusion Criteria:

  1. Clinical evidence of severe peripheral vascular disease (Fazekas score of ≥ 3, or alarge vessel stroke of ≥ 2 cm, history of ulceration, poor wound healing, vascularclaudication)

  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

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Syn-One Test
Phase:
Study Start date:
August 15, 2022
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • CND Life Sciences

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • CenExel RMCR

    Englewood, Colorado 80113
    United States

    Site Not Available

  • University of Miami

    Boca Raton, Florida 33433
    United States

    Site Not Available

  • Neurology One

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Ochsner Research

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Mass General Hospital

    Boston, Massachusetts 02145
    United States

    Site Not Available

  • Dr. Marks, M.D., P.C.

    Plymouth, Massachusetts 02360
    United States

    Active - Recruiting

  • Headlands Research

    Plymouth, Massachusetts 02360
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37240
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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