MCI-AD, Early Stage Alzheimer's DiseaseNCT05479552
A Diagnostic Test for Dementia With Lewy Bodies
An observational study of MCI-AD, Early Stage Alzheimer's Disease and MCI-DLB, Early Stage Dementia With Lewy Bodies, run by CND Life Sciences at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- MCI-AD, Early Stage Alzheimer's Disease, MCI-DLB, Early Stage Dementia With Lewy Bodies
- What is being tested?
- Syn-One Test
- How many people
- 80 participants
- Where
- 12 sitesUnited States
- Study dates
- 15 Aug 2022to 31 Oct 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Michigan
Ann Arbor, Michigan, 48105
University of Miami
Boca Raton, Florida, 33433
Mass General Hospital
Boston, Massachusetts, 02145
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
CenExel RMCR
Englewood, Colorado, 80113
University of California San Diego
La Jolla, California, 92037
Vanderbilt University Medical Center
Nashville, Tennessee, 37240
Ochsner Research
New Orleans, Louisiana, 70121
Headlands Research
Plymouth, Massachusetts, 02360
University of Utah
Salt Lake City, Utah, 84108
CND Life Sciences
Scottsdale, Arizona, 85258
Neurology One
Winter Park, Florida, 32792
About this study
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.
Read the 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.
- Being tested
- Syn-One Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syn-One TestDiagnostic test
CND Life Sciences is expanding the utility of its diagnostic technology, the Syn-One Test, to pathologically distinguish between early DLB and Alzheimer's disease to prevent misdiagnoses and establish the relationship between progression and α-synuclein deposition by measuring α- synuclein accumulation in patient's nerve fibers using a simple skin punch biopsy.
| Study group | Role | What they receive |
|---|---|---|
| MCI-AD | 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). Receives: Diagnostic Test: Syn-One Test | |
| MCI-DLB | 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). Receives: Diagnostic Test: Syn-One Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
To pathologically distinguish DLB from AD early in the course of the disease using the Syn-One TestTM, confirming disease diagnosis through prospective clinical assessments and follow up biopsy analyses over 12 months.
Measured: 2 years
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.
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.
Measured: 2 years
Secondary outcomes (2)
Secondary Aim 1
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.
Measured: 2 years
Secondary Aim 2
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start15 Aug 2022
- Primary completion28 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MCI-AD, Early Stage Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CND Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Todd Levine, MD, Principal investigator, CND Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479552
- Sponsor's protocol ID
- 101
- Other IDs
- R44AG076072
- Status last verified
- Jan 2025
- First submitted
- 22 Jul 2022
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared with researchers that are involved in the study.
Publications
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.
PubMed 35272481Gibbons CH, Galasko D, Press D, Claassen D, Levine T, Freeman R. The Syn-D study: detection of cutaneous phosphorylated alpha-synuclein in mild cognitive impairment a trial protocol. Biomark Med. 2025 Jul;19(13):501-508. doi: 10.1080/17520363.2025.2520154. Epub 2025 Jun 16.
PubMed 40523872