Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528964
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Proteinopathies Expression in Skin of Neurodegenerative Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Expression of Proteinopathies in Skin Biopsies of Patients With Neurodegenerative Disorders
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Alzheimers disease frontotemporal lobe dementia Parkinsons 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
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
Detailed Description:
Alzheimers disease is the main cause of neurodegenerative dementia and represents a high degree of morbidity and mortality among the patients who have it causing a great economic impact in health systems In general population the second cause of neurodegenerative dementia is frontotemporal lobe dementia and its also the first cause of dementia in patients under 65 years old
Neurodegenerative diseases have been associated with the deposit of abnormal aggregated proteins like alpha-synuclein amyloid-beta phosphorylated tau and TAR DNA binding protein 43 in brain tissue Similar deposits of a-synuclein p-TAU and TDP-43 have been identified through immunohistochemistry and immunofluorescence in skin biopsies
Main objective Compare the aggregation pattern between the different proteinopathies a-synuclein amyloid-b p-TAU and TDP-43 with immunohistochemistry in skin biopsies of patients with Alzheimers disease frontotemporal lobe dementia Parkinsons disease atypical Parkinsonism amyotrophic lateral sclerosis and normal pressure hydrocephalus vs control subjects
Study design this will be an observational transversal and comparative analysis study Inclusion criteria patients men and women 45 and older diagnosed with Alzheimers disease frontotemporal lobe dementia Parkinsons disease atypical Parkinsonism amyotrophic lateral sclerosis or normal pressure hydrocephalus will be recruited for sampling with skin biopsy Healthy control subjects will be men or women similar in age to the patients that dont have any personal or family history of a neurodegenerative disease and that are not related by blood to the patients in this study
Sample size calculation and statistical analysis
All the patients that meet the inclusion criteria and accept the consent form from the neurology department of Hospital Central Dr Ignacio Morones Prieto will be recruited for one year
A descriptive analysis will be carried out with frequencies and percentages for categorical variables for continuous variables central tendency and dispersion analysis the normality of the data will be evaluated using the Kolmogorov-Smirnov or Shapiro-Wilk test as appropriate In case the data ha a normal distribution it will be analyzed with the ANOVA test followed by Tukey and in the case the data doesnt have a normal distribution the analysis will be made with Kruskal Wallis followed by Mann Whitney U
Neurodegenerative diseases have been associated with the deposit of abnormal aggregated proteins like alpha-synuclein amyloid-beta phosphorylated tau and TAR DNA binding protein 43 in brain tissue Similar deposits of a-synuclein p-TAU and TDP-43 have been identified through immunohistochemistry and immunofluorescence in skin biopsies
Main objective Compare the aggregation pattern between the different proteinopathies a-synuclein amyloid-b p-TAU and TDP-43 with immunohistochemistry in skin biopsies of patients with Alzheimers disease frontotemporal lobe dementia Parkinsons disease atypical Parkinsonism amyotrophic lateral sclerosis and normal pressure hydrocephalus vs control subjects
Study design this will be an observational transversal and comparative analysis study Inclusion criteria patients men and women 45 and older diagnosed with Alzheimers disease frontotemporal lobe dementia Parkinsons disease atypical Parkinsonism amyotrophic lateral sclerosis or normal pressure hydrocephalus will be recruited for sampling with skin biopsy Healthy control subjects will be men or women similar in age to the patients that dont have any personal or family history of a neurodegenerative disease and that are not related by blood to the patients in this study
Sample size calculation and statistical analysis
All the patients that meet the inclusion criteria and accept the consent form from the neurology department of Hospital Central Dr Ignacio Morones Prieto will be recruited for one year
A descriptive analysis will be carried out with frequencies and percentages for categorical variables for continuous variables central tendency and dispersion analysis the normality of the data will be evaluated using the Kolmogorov-Smirnov or Shapiro-Wilk test as appropriate In case the data ha a normal distribution it will be analyzed with the ANOVA test followed by Tukey and in the case the data doesnt have a normal distribution the analysis will be made with Kruskal Wallis followed by Mann Whitney U
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None