Evidence map›Paper›PMID 40523872›Full record

ArticleBiomarkers in medicine2025

The Syn-D study: detection of cutaneous phosphorylated alpha-synuclein in mild cognitive impairment a trial protocol.

Christopher H Gibbons, Douglas Galasko, Daniel Press, Daniel Claassen, Todd Levine, Roy Freeman

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Biomarkers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05479552 (A Diagnostic Test for Dementia With Lewy Bodies), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05479552 active not recruitingnot on this map

A Diagnostic Test for Dementia With Lewy Bodies

TypeobservationalSponsorCND Life SciencesRan2022 to 2025Enrolled80ConditionsMCI-AD, Early Stage Alzheimer's Disease, MCI-DLB, Early Stage Dementia With Lewy BodiesArmsSyn-One Test
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Christopher H GibbonsDepartment of Neurology Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Douglas GalaskoDepartment of Neurology, University of California, San Diego, USA.
Daniel PressDepartment of Neurology Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Daniel ClaassenDepartment of Neurology, Vanderbilt University, Nashville, TN, USA.
Todd LevineCND Life Sciences, Scottsdale, AZ, USA.
Roy FreemanDepartment of Neurology Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

Funding

UCSD Shiley-Marcos Alzheimer's Disease Research Center P30P30AG062429 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Mark W Bondi · 2019 to 2026
$34.9M
Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal SynucleinopathiesR44NS127696 · NINDS · CND LIFE SCIENCES, INC. · PI LEVINE, TODD · 2022 to 2024
$3.0M
A Diagnostic Test for Dementia with Lewy BodiesR44AG076072 · NIA · CND LIFE SCIENCES, INC. · PI LEVINE, TODD · 2022 to 2023
$2.4M
NIA NIH HHS P30 AG062429NIA NIH HHS R44 AG076072NINDS NIH HHS R44 NS127696
6 · The paper itself

Abstract

backgroundSkin biopsies have >95% sensitivity and specificity to detect the presence of phosphorylated alpha-synuclein (P-SYN).

objectiveTo determine the frequency of cutaneous P-SYN in patients with mild cognitive impairment (MCI) due to suspected Alzheimer's disease (AD) and dementia with Lewy bodies (DLB). DESIGN, SETTING AND

participantsThe Syn-D study is a multicenter prospective clinical trial from ~10 centers across the United States that includes patients with MCI-AD or MCI-DLB.

methodsPatients will undergo skin biopsies for detection of P-SYN and plasma biomarkers for ptau-217 to determine biomarker positivity rates at the MCI stage and will be followed longitudinally to determine final clinical diagnosis as defined by an expert panel of clinicians blinded to biomarker results. MAIN OUTCOMES AND MEASURES: The co-primary outcomes include: 1) The sensitivity of skin biopsy detection of P-SYN in patients with clinical diagnoses of MCI due to DLB or AD at baseline and at 12-month follow-up 2) To report the frequency with which cutaneous deposition of P-SYN and blood-based AD biomarkers co-exist in a population of patients with MCI. DISCUSSION: This will be the first

trial registrationNCT05479552.

Indexed as

alpha-SynucleinCognitive DysfunctionSkinAgedAlzheimer DiseaseBiomarkersBiopsyFemaleHumansLewy Body DiseaseMaleMulticenter Studies as TopicObservational Studies as TopicPhosphorylationProspective Studiesalpha-SynucleinBiomarkersalzheimer’s diseaseDementia with Lewy bodiesmild cognitive impairmentphosphorylated Alpha-synucleinskin biopsy

Identifiers

PMID40523872
PMCPMC12233825

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.