Combined analysis of phospho-tau and alpha-synuclein in different procedures of skinpunchbiopsies in the differentiation of neurodegenerative diseases, a prospective case-control study

Combined analysis of phospho-tau and alpha-synuclein in different procedures of skinpunchbiopsies in the differentiation of neurodegenerative diseases, a prospective case-control study - CATS-SND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020818

Enrollment

270

Registered

2020-02-13

Start date

2020-02-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G20.0 F02.3 G23.1 G23.2 G23.3 G31.9 F00.9 G31.0 I68.0 G47.8 G12.2

Interventions

Group 1: Patients with the diseases stated above All study participants receive a skin punch biopsy at C7 bilaterally. In the biopsy, p-tau and a-syn are detected respectively quantified. A follow-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Outpatient or inpatient presentation in the Clinic for Neurology or the ZGGF - Age > 18 years - Diagnosis of a PD, PDD, PD-MCI, DLB, MSA, CBD, PSP, AD, RBD, CAA, FTD, ALS according to the currently valid international diagnostic criteria - Healthy controls (HC) without the clinical presentation of PD, PDD, PD-MCI, DLB, MSA, CBD, PSP, AD, RBD, CAA, FTD, ALS,> 18 years, in inpatient treatment in the clinic for neurology or relatives of the patients mentioned above

Exclusion criteria

Exclusion criteria: - Lack of possibility of verbal and written information to the patient or the caregiver of the patient - Oral anticoagulation - known impairment of wound healing - Diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Determination of the sensitivity and specificity of the a-Syn and p-Tau load using Western blot, ELISA, TR-FRET, MSD in the skin for the differentiation between a-synucleinopathies and tauopathies, between PD and aPS and between PD, PDD, PD -MCI, DLB, MSA, CBD, PSP, AD, CAA, RBD, FTD, ALS als well as healthy controls. Diagnostic criteria for a positive or negative test result based on p-tau and a-Syn in a Western blot or by means of ELISA, TR-FRET or MSD will be developed within the project. The gold standard is the disease status according to the currently valid international diagnostic criteria without taking p-tau and a-Syn into account.	—

Measure

Time frame

Determination of the sensitivity and specificity of the a-Syn and p-Tau load using Western blot, ELISA, TR-FRET, MSD in the skin for the differentiation between a-synucleinopathies and tauopathies, between PD and aPS and between PD, PDD, PD -MCI, DLB, MSA, CBD, PSP, AD, CAA, RBD, FTD, ALS als well as healthy controls. Diagnostic criteria for a positive or negative test result based on p-tau and a-Syn in a Western blot or by means of ELISA, TR-FRET or MSD will be developed within the project. The gold standard is the disease status according to the currently valid international diagnostic criteria without taking p-tau and a-Syn into account.

—

Secondary

Measure	Time frame
Association of the a-Syn and tau load in the Western blot, ELISA, TR-FRET or MSD with clinical findings and the findings of various diagnostic procedures (FDG-PET, FP-CIT-SPECT, skin biopsy, cMRI, neurocognitive testing, disease stage), possibly association with the course of the disease in the case of renewed routine presentations in the neurological outpatient clinic.	—

Countries

Germany

Contacts

Public ContactNils Schröter

Klinik für Neurologie Universitätsklinikum Freiburg

nils.schroeter@uniklinik-freiburg.de0761-270-50010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026