A Diagnostic Test for Dementia With Lewy Bodies

CND Life Sciences

Status: Active, not recruiting

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

Treatments: Diagnostic Test: Syn-One Test

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05479552

R44AG076072 (U.S. NIH Grant/Contract)

101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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 or AD at enrollment

Exclusion criteria

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

Trial design

80 participants in 2 patient groups

MCI-AD

Description:

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).

Treatment:

Diagnostic Test: Syn-One Test

MCI-DLB

Description:

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).

Treatment:

Diagnostic Test: Syn-One Test