A Diagnostic Test for Dementia With Lewy Bodies
- Conditions
- MCI-DLB, Early Stage Dementia With Lewy BodiesMCI-AD, Early Stage Alzheimer's Disease
- Interventions
- Diagnostic Test: Syn-One Test
- Registration Number
- NCT05479552
- Lead Sponsor
- CND Life Sciences
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MCI-AD Syn-One Test Will be diagnosed using 'preclinical AD' criteria of mild cognitive impairment supported by a positive biomarker for AD. MCI defined as: 1. History of cognitive decline, noticed by either the patient, family member(s) or a medical practitioner but still independent in most complex daily activities. 2. Documentation of cognition not normal e.g., by MoCA or neuropsychological testing; 3. Does not meet the definition of dementia with MOCA \<18 or global CDR 1 or greater (although exceptions may exist with appropriate justification). 4. Supportive AD biomarker (has positive biomarkers for both Aβ and neuronal injury using CSF or neuroimaging). MCI-DLB Syn-One Test Will be diagnosed as prodromal probable MCI-DLB based on consensus criteria using 2 or more core clinical features of DLB (with or without the presence of biomarkers) or 1 or more core clinical features with 1 or more indicative biomarkers (reduced dopamine transporter uptake in basal ganglia demonstrated by SPECT or PET reduced Iodine-MIBG uptake on myocardial scintigraphy, PSG confirmation of REM without atonia).
- 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. 2 years To define the rates of neuronal degeneration in DLB through systematic pathological quantitation of skin biopsies measuring P-SYN deposition and cutaneous nerve fiber degeneration, compared to AD, and correlating pathological findings with clinical assessments over the course of 12 months.
- Secondary Outcome Measures
Name Time Method Secondary Aim 1 2 years The outcome measure will be an ordinal quantitation of P-SYN deposition within skin biopsies. The primary endpoint for is sensitivity and specificity of results in DLB and AD. We predict that a threshold of P-SYN \>0 is a "positive" result and will separate DLB from AD using dichotomous measures, but ROC curve analysis will be performed to maximize sensitivity and specificity using continuous quantitative measurement of P- SYN.
Secondary Aim 2 2 years Will include P-SYN deposition, SGNFD, PMNFD and IENFD as continuous variables for statistical analysis. Data will be compared first using repeated measures Analysis of Covariance (ANCOVA), with DLB as the predictor variable. The primary dependent variable is the quantitative measure of P-SYN deposition.
Trial Locations
- Locations (12)
CND Life Sciences
🇺🇸Scottsdale, Arizona, United States
University of California San Diego
🇺🇸La Jolla, California, United States
CenExel RMCR
🇺🇸Englewood, Colorado, United States
University of Miami
🇺🇸Boca Raton, Florida, United States
Neurology One
🇺🇸Winter Park, Florida, United States
Headlands Research
🇺🇸Plymouth, Massachusetts, United States
Ochsner Research
🇺🇸New Orleans, Louisiana, United States
Mass General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States