Parkinson DiseaseNCT01380899
Usefulness of α-synuclein as a Marker for Early Diagnosis of Parkinson's Disease in Skin Biopsy.
An observational study of Parkinson Disease and Parkinsonian Disorders, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Parkinsonian Disorders
- What is being tested?
- Biopsy of skin
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 87 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2011to Oct 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients will be selected from the department of neurology and the office of the principal investigator.
Who may be able to join
- 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
Who cannot join
- History of stroke or/and trauma
- Signs of cerebrovascular pathology
- Brain tumor
- Severe unrelated neurological or physical disease
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, 78290
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Parkinson Disease, Parkinsonian Disorders
- Being tested
- Biopsy of skin
- Keywords
- Parkinson Disease, Parkinsonian Disorders, Lewy Bodies, alpha-Synuclein
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of skinProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PD Parkinson´s Disrease | We are studying the presence of alpha-synuclein in the epidermis and dermis besides the end nerve terminal. We have several reports until now, and we are following the study because we wish to convince the academic and scientific society over the utility of this study to be close to the molecular diagnosis of this kind of disease. Receives: Procedure: Biopsy of skin | |
| AP Atypical Parkinsonism | with neurodegenerative disease (proteinopathies) and secondary AP. | |
| Control group | Subjects without neurodegenerative disease and apparently good health status with an age that matches the problems groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The presence in the brain of a-synuclein containing Lewy neurites, or bodies, is the histological hallmark of Parkinson's disease (PD).
The discovery of alpha-synuclein aggregates in nerve endings of the heart, digestive tract, and skin has lent support to the concept of PD as a systemic disease.
First, our goal was to demonstrate the presence of alpha-synuclein inclusions in the skin of PD patients.
Second, to detect quantitative differences (measures in the percentage of presence in the skin´s cells) between patients with PD, atypical parkinsonism (AP), compared with an apparent healthy group.
Measured: An average of seven days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ildefonso Rodriguez-Leyva, Universidad Autonoma de San Luis Potosí
- Investigators
- Ildefonso Rodríguez-Leyva, MD, Principal investigator, Hospital Central "Dr. Ignacio Morones Prieto"Maria E Jimenez-Capdeville, PhD, Study director, Universidad Autonoma de San Luis PotosiJuan P Castanedo-Cazares, MD, Study director, Hospital Dr. Ignacio Morones PrietoErika G Chi-Ahumada, MC, Study chair, Facultad de Medicina, UASLPMaria E Jimenez-Capdeville, PhD, Study chair, Facultad de MedicinaRobert A. Norman, MD, PhD., Study chair, Independent Dermatologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380899
- Sponsor's protocol ID
- UASLP-PD001
- Status last verified
- May 2021
- First submitted
- 17 Jun 2011
- Last updated
- 25 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Each participant has to sign the concern form. We can share his clinical data, but not private information.
Publications
Nutt JG, Wooten GF. Clinical practice. Diagnosis and initial management of Parkinson's disease. N Engl J Med. 2005 Sep 8;353(10):1021-7. doi: 10.1056/NEJMcp043908. No abstract available.
PubMed 16148287Gelb DJ, Oliver E, Gilman S. Diagnostic criteria for Parkinson disease. Arch Neurol. 1999 Jan;56(1):33-9. doi: 10.1001/archneur.56.1.33.
PubMed 9923759Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.
PubMed 1564476Tuite PJ, Krawczewski K. Parkinsonism: a review-of-systems approach to diagnosis. Semin Neurol. 2007 Apr;27(2):113-22. doi: 10.1055/s-2007-971174.
PubMed 17390256Ibanez-Salazar A, Banuelos-Hernandez B, Rodriguez-Leyva I, Chi-Ahumada E, Monreal-Escalante E, Jimenez-Capdeville ME, Rosales-Mendoza S. Oxidative Stress Modifies the Levels and Phosphorylation State of Tau Protein in Human Fibroblasts. Front Neurosci. 2017 Sep 7;11:495. doi: 10.3389/fnins.2017.00495. eCollection 2017.
PubMed 28936161Rodriguez-Leyva I, Calderon-Garciduenas AL, Jimenez-Capdeville ME, Renteria-Palomo AA, Hernandez-Rodriguez HG, Valdes-Rodriguez R, Fuentes-Ahumada C, Torres-Alvarez B, Sepulveda-Saavedra J, Soto-Dominguez A, Santoyo ME, Rodriguez-Moreno JI, Castanedo-Cazares JP. alpha-Synuclein inclusions in the skin of Parkinson's disease and parkinsonism. Ann Clin Transl Neurol. 2014 Jul;1(7):471-8. doi: 10.1002/acn3.78. Epub 2014 Jul 1.
PubMed 25356418Rodriguez-Leyva I, Chi-Ahumada EG, Carrizales J, Rodriguez-Violante M, Velazquez-Osuna S, Medina-Mier V, Martel-Gallegos MG, Zarazua S, Enriquez-Macias L, Castro A, Calderon-Garciduenas AL, Jimenez-Capdeville ME. Parkinson disease and progressive supranuclear palsy: protein expression in skin. Ann Clin Transl Neurol. 2016 Feb 1;3(3):191-9. doi: 10.1002/acn3.285. eCollection 2016 Mar.
PubMed 27042679Rodriguez-Leyva I, Chi-Ahumada E, Mejia M, Castanedo-Cazares JP, Eng W, Saikaly SK, Carrizales J, Levine TD, Norman RA, Jimenez-Capdeville ME. The Presence of Alpha-Synuclein in Skin from Melanoma and Patients with Parkinson's Disease. Mov Disord Clin Pract. 2017 Jun 1;4(5):724-732. doi: 10.1002/mdc3.12494. eCollection 2017 Sep-Oct.
PubMed 30363411Mejia M, Rodriguez-Leyva I, Cortes-Enriquez F, Chi-Ahumada E, Portales-Perez DP, Macias-Islas MA, Jimenez-Capdeville ME. Low levels of alpha-synuclein in peripheral tissues are related to clinical relapse in relapsing-remitting multiple sclerosis: a pilot cross-sectional study. J Neurol Sci. 2019 Jan 15;396:87-93. doi: 10.1016/j.jns.2018.11.003. Epub 2018 Nov 3.
PubMed 30445232Jimenez-Capdeville ME, Chi-Ahumada E, Garcia-Ortega F, Castanedo-Cazares JP, Norman R, Rodriguez-Leyva I. Nuclear Alpha-Synuclein in Parkinson's Disease and the Malignant Transformation in Melanoma. Neurol Res Int. 2025 Jan 6;2025:1119424. doi: 10.1155/nri/1119424. eCollection 2025.
PubMed 39816956
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of α-synuclein as a Marker for Early Diagnosis of Parkinson's Disease in Skin Biopsy.
- ClinicalTrials.gov ID
- NCT01380899
- Acronym / sponsor ID
- UASLP-PD001
- Conditions
- Parkinson Disease, Parkinsonian Disorders
- Keywords
- Parkinson Disease, Parkinsonian Disorders, Lewy Bodies, alpha-Synuclein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PD Parkinson´s Disrease | – | Procedure: Biopsy of skinWe are studying the presence of alpha-synuclein in the epidermis and dermis besides the end nerve terminal. We have several reports until now, and we are following the study because we wish to convince the academic and scientific society over the utility of this study to be close to the molecular diagnosis of this kind of disease. |
| AP Atypical Parkinsonism | – | –with neurodegenerative disease (proteinopathies) and secondary AP. |
| Control group | – | –Subjects without neurodegenerative disease and apparently good health status with an age that matches the problems groups |
Who may qualify
- Ages
- 35 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be selected from the department of neurology and the office of the principal investigator.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- History of stroke or/and trauma
- Signs of cerebrovascular pathology
- Brain tumor
- Severe unrelated neurological or physical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy of skinUnder 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. | Procedure or surgery | PD Parkinson´s Disrease |
Primary outcome
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.
Time frame: An average of seven days.
The presence in the brain of a-synuclein containing Lewy neurites, or bodies, is the histological hallmark of Parkinson's disease (PD). The discovery of alpha-synuclein aggregates in nerve endings of the heart, digestive tract, and skin has lent support to the concept of PD as a systemic disease. First, our goal was to demonstrate the presence of alpha-synuclein inclusions in the skin of PD patients. Second, to detect quantitative differences (measures in the percentage of presence in the skin´s cells) between patients with PD, atypical parkinsonism (AP), compared with an apparent healthy group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16148287Nutt JG, Wooten GF. Clinical practice. Diagnosis and initial management of Parkinson's disease. N Engl J Med. 2005 Sep 8;353(10):1021-7. doi: 10.1056/NEJMcp043908. No abstract available.
- Background: PubMed 9923759Gelb DJ, Oliver E, Gilman S. Diagnostic criteria for Parkinson disease. Arch Neurol. 1999 Jan;56(1):33-9. doi: 10.1001/archneur.56.1.33.
- Background: PubMed 1564476Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.
- Background: PubMed 17390256Tuite PJ, Krawczewski K. Parkinsonism: a review-of-systems approach to diagnosis. Semin Neurol. 2007 Apr;27(2):113-22. doi: 10.1055/s-2007-971174.
- Background: PubMed 28936161Ibanez-Salazar A, Banuelos-Hernandez B, Rodriguez-Leyva I, Chi-Ahumada E, Monreal-Escalante E, Jimenez-Capdeville ME, Rosales-Mendoza S. Oxidative Stress Modifies the Levels and Phosphorylation State of Tau Protein in Human Fibroblasts. Front Neurosci. 2017 Sep 7;11:495. doi: 10.3389/fnins.2017.00495. eCollection 2017.
- Results publication: PubMed 25356418Rodriguez-Leyva I, Calderon-Garciduenas AL, Jimenez-Capdeville ME, Renteria-Palomo AA, Hernandez-Rodriguez HG, Valdes-Rodriguez R, Fuentes-Ahumada C, Torres-Alvarez B, Sepulveda-Saavedra J, Soto-Dominguez A, Santoyo ME, Rodriguez-Moreno JI, Castanedo-Cazares JP. alpha-Synuclein inclusions in the skin of Parkinson's disease and parkinsonism. Ann Clin Transl Neurol. 2014 Jul;1(7):471-8. doi: 10.1002/acn3.78. Epub 2014 Jul 1.
- Results publication: PubMed 27042679Rodriguez-Leyva I, Chi-Ahumada EG, Carrizales J, Rodriguez-Violante M, Velazquez-Osuna S, Medina-Mier V, Martel-Gallegos MG, Zarazua S, Enriquez-Macias L, Castro A, Calderon-Garciduenas AL, Jimenez-Capdeville ME. Parkinson disease and progressive supranuclear palsy: protein expression in skin. Ann Clin Transl Neurol. 2016 Feb 1;3(3):191-9. doi: 10.1002/acn3.285. eCollection 2016 Mar.
- Results publication: PubMed 30363411Rodriguez-Leyva I, Chi-Ahumada E, Mejia M, Castanedo-Cazares JP, Eng W, Saikaly SK, Carrizales J, Levine TD, Norman RA, Jimenez-Capdeville ME. The Presence of Alpha-Synuclein in Skin from Melanoma and Patients with Parkinson's Disease. Mov Disord Clin Pract. 2017 Jun 1;4(5):724-732. doi: 10.1002/mdc3.12494. eCollection 2017 Sep-Oct.
- Results publication: PubMed 30445232Mejia M, Rodriguez-Leyva I, Cortes-Enriquez F, Chi-Ahumada E, Portales-Perez DP, Macias-Islas MA, Jimenez-Capdeville ME. Low levels of alpha-synuclein in peripheral tissues are related to clinical relapse in relapsing-remitting multiple sclerosis: a pilot cross-sectional study. J Neurol Sci. 2019 Jan 15;396:87-93. doi: 10.1016/j.jns.2018.11.003. Epub 2018 Nov 3.
- Derived from this study: PubMed 39816956Jimenez-Capdeville ME, Chi-Ahumada E, Garcia-Ortega F, Castanedo-Cazares JP, Norman R, Rodriguez-Leyva I. Nuclear Alpha-Synuclein in Parkinson's Disease and the Malignant Transformation in Melanoma. Neurol Res Int. 2025 Jan 6;2025:1119424. doi: 10.1155/nri/1119424. eCollection 2025.
- Individual participant dataSharing planned: No. Each participant has to sign the concern form. We can share his clinical data, but not private information.
Related trials for Parkinson Disease
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
Not yet recruiting
The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease
Parkinson Disease
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ildefonso Rodríguez-Leyva, MD principal investigator
Hospital Central "Dr. Ignacio Morones Prieto"
Maria E Jimenez-Capdeville, PhD study director
Universidad Autonoma de San Luis Potosi
Juan P Castanedo-Cazares, MD study director
Hospital Dr. Ignacio Morones Prieto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Parkinsonian Disorders, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: An average of seven days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01380899, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.