Clinical trial NCT05479552: A Diagnostic Test for Dementia With Lewy Bodies
Official title: A Diagnostic Test for Dementia With Lewy Bodies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: MCI-AD, Early Stage Alzheimer's Disease
MCI-DLB, Early Stage Dementia With Lewy Bodies
Lead sponsor: CND Life Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-07-29
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects evaluated in the protocol will have a diagnosis of mild dementia with Lewy bodies (MCI-DLB) or mild Alzheimer's disease (MCI-AD). Patients will be evaluated at Baseline and 12 months. A total of 80 individuals will be enrolled, 40 with MCI-DLB and 40 with MCD-AD, with roughly equal representation of men and women.

All subjects will undergo screening evaluation that includes a thorough medical history, physical and neurologic examination and review of available medical records, laboratory studies, neuroimaging and sleep laboratory studies.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Secondary Aim 1
timeFrame: 2 years
measure: Secondary Aim 2
timeFrame: 2 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CND Life Sciences
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Englewood
country: United States
facility: CenExel RMCR
state: Colorado
city: Boca Raton
country: United States
facility: University of Miami
state: Florida
city: Winter Park
country: United States
facility: Neurology One
state: Florida
city: New Orleans
country: United States
facility: Ochsner Research
state: Louisiana
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Plymouth
country: United States
facility: Headlands Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: CND Life Sciences
name: Todd Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibbons CH, Freeman R, Bellaire B, Adler CH, Moore D, Levine T. Synuclein-One study: skin biopsy detection of phosphorylated alpha-synuclein for diagnosis of synucleinopathies. Biomark Med. 2022 May;16(7):499-509. doi: 10.2217/bmm-2021-0646. Epub 2022 Mar 11.