Predictors of Parkinson's Disease Progression (PDPROG-EGY)

March 9, 2023 updated by: Ali Shalash, Ain Shams University

Predictors of Parkinson's Disease Progression in Sample of Egyptian Patients; Clinical and Biochemical

it is a prospective longitudinal observational study, aiming to to identify clinical, and biochemical baseline predictors of motor and non-motor PD progression in sample of Egyptian patients. it measures the baseline motor, non-motor, biochemical and imaging characteristics at enrollment and its relation to PD progression over 3 years

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

it is a prospective longitudinal observational study, aiming to to identify clinical, and biochemical baseline predictors of motor and non-motor PD progression in sample of Egyptian patients. it measures the baseline motor, non-motor, biochemical and imaging characteristics at enrollment and its relation to PD progression over 3 years.

The aim of this study is to identify clinical, and biochemical baseline predictors of motor and non-motor PD progression in sample of Egyptian patients.

Methods:

Assessment:-

Time • During the 2 years recruitment of patients from 2019 to 2021, the assessment will be at base line (first clinic visit), after 1yr, and after 2yrs.

Patients will be subjected to:

Clinical assessment:

  • At base line, Patients will complete an extensive clinical evaluation, including:

    1. Comprehensive medical history and neurological examination.
    2. Demographic information (sex, age, education level, and occupation), as well as clinical characteristics of them (age at onset, duration of illness, received medications and doses).
    3. Motor assessment; Movement Disorder Society (MDS) -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) he motor portion (Part III) during OFF and ON states, Hoehn & Yahr, and Schwab & England scales.

    4. Gait assessment, Gait will be assessed by:

      Freezing of gait questionnaire Berg balance scale 10 m walk test Timed up and go test

      Physical activity scale for elderly (PASE). Cognitive assessment; MOCA, MMSE. Cognitive assessment : during On state.

  • All patients will be evaluated for global cognitive assessment by:
  • Mini Mental State Examination (MMSE)Arabic version
  • Montreal Cognitive Assessment (MoCA) Arabic version

  • The standard battery included cognitive tests in the following domains: visuospatial skills, language, attention, executive functioning, and memory.

    • Visuospatial skills will be assessed by clock drawing test and copy the intersecting pentagons of Addenbrooke's test (Arabic version)
    • Language will be examined by Language similarity & language subset of Addenbrooke's test (Arabic version)
    • Attention will be evaluated by forward &backward digit span tests and by the number of seconds needed to sequence numbers using a pencil (Trail making test A)
    • For the evaluation of memory, participants will complete Wechsler memory subset, and investigators also will use their three-item recall from the MMSE.
    • Executive functions will be measured by Wisconsin card sorting test and also Semantic verbal fluency test .

The non-motor symptoms scales (NMSS). Beck depression inventory (BDI). The Arabic version of The Parkinson's Disease Questionnaire (PDQ-39). Lab investigations MRI brain or CT brain . Serum alpha -Synuclein auto antibodies

All the following will be done at baseline, after 1 year, and after 2 year except, MRI brain and serum alpha-synuclein (only at baseline ).

This study will be approved from the ethical committee of Faculty of Medicine, Ain -Shams University.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Recruiting
        • Ain Shams Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All idiopathic Parkinson patients attending movement disorder clinic meeting the inclusion criteria.

Description

Inclusion Criteria:

  • • All are Arabic-speaking individuals diagnosed with PD by a movement disorder neurologist based on the UK bank criteria for idiopathic Parkinson's disease.

    • An oral informed consent will be taken from the cases before they participate in the study.

Exclusion Criteria:

  • Patients with red flag for being diagnosed with IPD and indicating secondary eg: vascular, Neuroleptics or atypical parkinsonism , progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration syndrome, Lewy body dementia

    • Patients with with other comorbid chronic diseases
    • PD patients who refused or could not complete questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case group
patients diagnosed with idiopathic paaarkinson's disease according to the clinical criteria.
Diagnostic test: serum alpha synuclein autoantibodies, motor and non motor scales
measuring serum alpha synuclein autoantibodies by ELIZA at baseline assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictors of progression of motor features of PD
Time Frame: at 1, 2,3 years follow ups
change in MDS UPDRS, Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS), from 0 to 260. The MDS-UPDRS has four parts, namely, I: Non-motor Experiences of Daily Living (13 questions) total is from 0 to 52; II: Motor Experiences of Daily Living (13 questions, from 0 to 52) III: Motor Examination (20 questions), total is from 0 to 132; IV: Motor Complications (6 questions, from 0 to 24). In each question: 0=normal; 1=slight; 2= mild; 3=moderate; 4=severe.higher values represent a worse outcome
at 1, 2,3 years follow ups
predictors of progression of non motor features of PD
Time Frame: at 1, 2 ,3 years follow-ups

changes in Nonmotor, and depression scores.

Non-Motor Symptom assessment scale for Parkinson's Disease, Symptoms assessed over the last month. Each symptom scored with respect to:

Severity: from 0 to 3 Frequency: from 1 to 4 Yes/ No answers are not included. score of each question = frequency x severity . There are nine domains: Cardiovascular including falls, Sleep/fatigue, Mood/cognition, Perceptual problems/hallucinations, Attention/memory, Gastrointestinal tract, Urinary, Sexual function, and Miscellaneous. Higher values represent worse outcome.

Depression assessment scales: Beck depression inventory (BDI) (Higher values represent worse outcome, Arabic version)
at 1, 2 ,3 years follow-ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
development of drug (levodopa) complications
Time Frame: at 1,2, and 3 years
follow up patients regarding appearance of levodopa related complications using Assessment will be done by Unified Dyskinesia Rating Scale (UDysRS) which is developed to evaluate involuntary movements often associated with treated Parkinson's disease. There are two primary sections: Historical [Part 1 (On-Dyskinesia) and Part 2 (Off-Dystonia)], and Objective [Part 3 (Impairment) and Part 4 (Disability)]
at 1,2, and 3 years
development of gait problems
Time Frame: at1,2, and 3 years
detecting changes in patients gait. Assessment of gait by Freezing of gait questionnaire (contain 9 questions allocated in 3 parts, score of each question ranges from 0; very mild freezing of gait to 3 or 4 ; with sever freezing of gait), Berg balance scale(to assess the static and dynamic balance by 14 questions with total score =56, each question scored from 0; the sever impairment , to 4 without impairment), 10 meter walk test (individual walks without assistance 10 meters (32.8 feet) and the time is measured, calculate the average of the three trials), and Timed up and go test.
at1,2, and 3 years
change of quality of life
Time Frame: at 1, 2 ,3 years
The Arabic version of Parkinson's Disease Questionnaire (PDQ-39), Higher values represent better outcome.
at 1, 2 ,3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of dementia and mild cognitive impairment in PD patients
Time Frame: at base line assessment in the first year
detected by baseline assessment of cognitive functions, using Cognitive scale: Montreal Cognitive Assessment (MoCA) (Arabic version), Visuospatial skills will be assessed by 3-D Wire Cube from Addenbrooke, and Clock Drawing Tests from MoCA test, Language will be examined by semantic fluency Addenbrooke's test (Arabic version), and similarities from IQ Wechsler test, Attention will be evaluated by DIGIT SPAN FROM WECHSLER MEMORY Trail making from MoCA) For the evaluation of memory, participants will complete Wechsler memory subset, and investigators also will use their three-item recall from the Mini-Mental State Examination ( MMSE), Executive functions will be measured by Wisconsin card sorting test and also verbal fluency test from Addenbrooke's test. Higher values represent worse outcome.
at base line assessment in the first year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ali Shalash, professor, Ain Shams Univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

August 18, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R58/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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