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

Ain Shams University

Status: Enrolling

Conditions: Biomarkers; Parkinson Disease; Cognitive Dysfunction

Treatments: Diagnostic Test: serum alpha synuclein autoantibodies, motor and non motor scales

Study type: Observational

Funder types: Other

Identifiers

NCT04062279

R58/2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

case group

Description:

patients diagnosed with idiopathic paaarkinson's disease according to the clinical criteria.

Treatment:

Diagnostic Test: serum alpha synuclein autoantibodies, motor and non motor scales