N/A
N=87
Usefulness of α-synuclein as a Marker for Early Diagnosis of Parkinson's Disease in Skin Biopsy.
Parkinson Disease · Parkinsonian Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01380899 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Demonstrate the Presence of Alpha-Synuclein Inclusions in the Skin of Parkinson's Disease and Compare With an Atypical Parkinsonism Group and With a Healthy Control Group. — 57.9; 6.9; 0; 62.1 percentage of expression — p=< 0.01
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Biopsy of skin (Procedure)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Universidad Autonoma de San Luis Potosí
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Demonstrate the Presence of Alpha-Synuclein Inclusions in the Skin of Parkinson's Disease and Compare With an Atypical Parkinsonism Group and With a Healthy Control Group. |
57.9; 6.9; 0; 62.1; 7.7; 0 | < 0.01 sig |
Summary
Parkinson's disease (PD) is a degenerative disease that can be difficult to diagnose. The clinicopathological studies had demonstrated a 76% accuracy in the clinical diagnosis of PD.
At the beginning of PD is difficult for the clinician to distinguish from Parkinsonism Plus Syndromes (PPS) due to the similarity of symptoms and the lack of specific diagnostic tests.
Specific biomarkers to help improve the accuracy of diagnosis and to separate these two entities are highly needed
The histological hallmark for definite diagnosis of PD is the presence of fibrillar aggregates of phosphorylated alpha-synuclein called Lewy bodies (LBs) and Lewy neurites. Previous autopsy-based studies have revealed that alpha-synuclein is deposited in the peripheral autonomic nervous system including the enteric nervous system of the alimentary tract, cardiac plexus, adrenal medulla and skin.
For this reason, in patients with parkinsonism, an alternative tool could be to demonstrate alpha-synuclein fibrillar aggregates in the skin, allowing early and appropriate diagnosis.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of Parkinson's Disease or Parkinson Plus Syndrome
- Subject is a male or female between the age of 50 and 95
- Subject will write the informed consent
Exclusion Criteria
- History of stroke or/and trauma
- Signs of cerebrovascular pathology
- Brain tumor
- Severe unrelated neurological or physical disease
Data sourced from ClinicalTrials.gov (NCT01380899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.