Usefulness of α-synuclein as a Marker for Early Diagnosis of Parkinson's Disease in Skin Biopsy.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Universidad Autonoma de San Luis Potosí.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Ildefonso Rodriguez-Leyva, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:
NCT01380899
First received: June 17, 2011
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Parkinson Disease
Parkinsonian Disorders
Procedure: Biopsy of skin

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Usefulness of α-synuclein as a Marker for Early Diagnosis of Parkinson's Disease in Skin Biopsy.

Resource links provided by NLM:


Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:
  • Fraction area of Alpha synuclein expression determined by immunohistochemistry in skin from patients with Parkinson disease and Parkinson Plus Syndromes, as a measure of selectively differentiate these two conditions. [ Time Frame: From date of clinical evaluation until the date of final report, assessed up to six months. ] [ Designated as safety issue: No ]
    Alpha synuclein will be analysed by means of immunohistochemistry in skin samples of patients with Parkinson syndrome contrasted to patients with Parkinson Plus Syndromes, as a possible marker to differentiate between them.


Estimated Enrollment: 23
Study Start Date: February 2011
Estimated Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PD alpha-synuclein Procedure: Biopsy of skin
Under local anesthesia with 1% xylocaine, 4-mm punch biopsies with 3-mm depth, including the dermis and subcutaneous fat tissue, will undergone from two regions, neck and lower back.
PPS alpha-synuclein Procedure: Biopsy of skin
Under local anesthesia with 1% xylocaine, 4-mm punch biopsies with 3-mm depth, including the dermis and subcutaneous fat tissue, will undergone from two regions, neck and lower back.

Detailed Description:

Parkinsonism, the syndrome, is a common movement disorder, and Parkinson's disease, the most common cause of parkinsonism, is the second most prevalent neurodegenerative disease after Alzheimer's disease.

The clinical diagnosis of PD is based on the presence of the four common features: tremor when the limb is at rest, resistance to passive movement of the joints (rigidity), slowness and paucity of movement (bradykinesia and akinesia) and postural abnormalities.

Approximately 25 percent of patients who received an initial clinical diagnosis of PD are found to have parkinsonism as part of another disorder, such as one of the so-called Parkinsonism-Plus Syndromes (PPS) The number and complexity of PPS seem to be increasing. This, along with the lack of diagnostic tests, makes it difficult for the clinician to distinguish between disease types.

Some characteristic clinical features are used for the differential diagnosis, this manifestations include early and severe postural instability, falls in the first year of onset, abnormal eye movements, autonomic dysfunction, cerebellar signs and upper motor neuron signs. The PPS respond poorly to antiparkinsonian medications and have a worse prognosis than does PD. In spite of these suggestive features, not all PD patients have the same progression, in some cases it is impossible to separate typical PD from PPS, especially at the early stage. In this context, biological markers must be of great usefulness for the differential diagnosis of these entities.

Some reports have described early features of PD such as (SPECT) imaging of the dopamine transporter that demonstrated the reduction of dopamine transporter in the striatum body at the early stage of PD and degeneration of the cardiac sympathetic nerve at the beginning of the disease process of PD; this occurs before neuronal cell loss is present in the dorsal vagal nucleus; This fact accounts for reduced cardiac uptake of meta-iodobenzylguanidine (MIBG), a physiological analog of norepinephrine. However, these diagnostic methods are not often performed. Therefore, more sensitive methods are needed to help improve the accuracy of diagnosis of PD.

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The patients will be selected from the department of neurology.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380899

Contacts
Contact: Ildefonso Rodríguez-Leyva, MD +52 4448176692 ilrole@yahoo.com.mx
Contact: Ana A Rentería-Palomo, MD +52 4448176692 arely_ana@hotmail.com

Locations
Mexico
Hospital Central Dr. Ignacio Morones Prieto Recruiting
San Luis Potosi, Mexico, 78290
Contact: Ildefonso Rodríguez-Leyva, MD    +52 4448176692    ilrole@yahoo.com.mx   
Contact: Ana A Rentería Palomo, MD    +52 4448176692    arely_ana@hotmail.com   
Principal Investigator: Ildefonso Rodriguez-Leyva, MD         
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
Hospital Central "Dr. Ignacio Morones Prieto"
Investigators
Study Chair: Ildefonso Rodríguez-Leyva, MD Hospital Central "Dr. Ignacio Morones Prieto"
Principal Investigator: Ana A Renteria-Palomo, MD Universidad Autonoma de San Luis Potosi
Study Director: Juan P Castanedo-Cazares, MD Hospital Dr. Ignacio Morones Prieto
Study Director: Bertha Torres-Alvarez, MD Hospital Central "Dr. Ignacio Morones Prieto"
  More Information

Publications:
Responsible Party: Ildefonso Rodriguez-Leyva, MD, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT01380899     History of Changes
Other Study ID Numbers: UASLP-PD001
Study First Received: June 17, 2011
Last Updated: September 30, 2011
Health Authority: Mexico: Ethics Committee
Mexico: Secretaria de Salud

Keywords provided by Universidad Autonoma de San Luis Potosí:
Parkinson Disease
Parkinsonian Disorders
Lewy Bodies
alpha-Synuclein

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014