Proteinopathies Expression in Skin of Neurodegenerative Disorders

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorUniversidad Autonoma de San Luis Potosí

About this trial

The goal of this observational study is to compare the aggregation pattern of proteinopathies (alpha-synuclein, amyloid-beta, phosphorylated tau and transactive response DNA -binding protein 43 \[TDP43\]) in skin biopsies of patients with a neurodegenerative disease like Alzheimer's disease, frontotemporal lobe dementia, Parkinson's disease, atypical Parkinsonism, amyotrophic lateral sclerosis or normal pressure hydrocephalus. The main question it aims to answer is:

* Is there a specific pattern of aggregation of proteinopathies in skin biopsies in each neurodegenerative disease in comparison to healthy control subjects?

Skin biopsies will be analyzed using immunohistochemistry and immunofluorescence for detection of alpha-synuclein, amyloid-beta, phosphorylated tau and TAR DNA binding protein 43, and the aggregation patterns will be compared between patients with a neurodegenerative disease vs patient with normal pressure hydrocephalus vs healthy control subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients 45 years and older

Men and women

Patients diagnosed with Alzheimer's disease, frontotemporal lobe dementia, Parkinson's disease, atypical Parkinsonism, amyotrophic lateral sclerosis or normal pressure hydrocephalus

Patients that voluntarily accept to participate in the study and accept the consent form

Disqualifiers

Patients or controls that have a personal history of cerebrovascular disease, psychiatric disease, post traumatic dementia or HIV related dementia

Patients in which the diagnosis is not clear or hasn't been confirmed

Patients or controls that have a neuroinfection

Patients or controls that a diagnosed skin disease

Trial population

The patients and controls that meet the eligibility criteria will be recruited from the neurology department consult from the Hospital Central Dr Ignacio Morones Prieto

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Immunohistochemistry and immunofluorescence

    Diagnostic test

    Skin biopsies will be analyzed using immunohistochemistry and immunofluorescence to detect the presence of aggregated a-synuclein, amyloid-b, p-TAU and TDP-43.

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Patients with neurodegenerative disease1 intervention
Group B: Patients with normal pressure hydrocephalus1 intervention
Group C: Healthy control subjects1 intervention

Trial outcomes

Primary outcomes

1

Aggregation pattern of a-synuclein, amyloid-b, p-TAU and TDP-43

The detection of each proteinopathy will be compared between each of them in every patient and compared to healthy control subjects.

Time frame
Each patient will be recruited and sampled the same day of the evaluation which will take about 1 hour. The final report it takes a frame time around two years.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Autonoma de San Luis Potosí

Lead sponsor

Hospital Central "Dr. Ignacio Morones Prieto"

Collaborator