Clinical trial NCT04062279: Predictors of Parkinson's Disease Progression
Official title: Predictors of Parkinson's Disease Progression in Sample of Egyptian Patients; Clinical and Biochemical
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Cognitive Dysfunction
Biomarkers
Keywords: Parkinson's disease
cognitive dysfunction
alpha synuclein
autoantibodies
progression
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All idiopathic Parkinson patients attending movement disorder clinic meeting the inclusion criteria.

Brief summary: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: predictors of progression of motor features of PD
timeFrame: at 1, 2,3 years follow ups
measure: predictors of progression of non motor features of PD
timeFrame: at 1, 2 ,3 years follow-ups
Secondary outcomes:
measure: development of drug (levodopa) complications
timeFrame: at 1,2, and 3 years
measure: development of gait problems
timeFrame: at1,2, and 3 years
measure: change of quality of life
timeFrame: at 1, 2 ,3 years
Other outcomes:
measure: frequency of dementia and mild cognitive impairment in PD patients
timeFrame: at base line assessment in the first year
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Univeristy
Study officials:
affiliation: Ain Shams Univeristy
name: Ali Shalash, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salama M, Shalash A, Magdy A, Makar M, Roushdy T, Elbalkimy M, Elrassas H, Elkafrawy P, Mohamed W, Abou Donia MB. Tubulin and Tau: Possible targets for diagnosis of Parkinson's and Alzheimer's diseases. PLoS One. 2018 May 9;13(5):e0196436. doi: 10.1371/journal.pone.0196436. eCollection 2018.
citation: Shalash A, Salama M, Makar M, Roushdy T, Elrassas HH, Mohamed W, El-Balkimy M, Abou Donia M. Elevated Serum alpha-Synuclein Autoantibodies in Patients with Parkinson's Disease Relative to Alzheimer's Disease and Controls. Front Neurol. 2017 Dec 22;8:720. doi: 10.3389/fneur.2017.00720. eCollection 2017.
citation: Shalash AS, Hassan DM, Elrassas HH, Salama MM, Mendez-Hernandez E, Salas-Pacheco JM, Arias-Carrion O. Auditory- and Vestibular-Evoked Potentials Correlate with Motor and Non-Motor Features of Parkinson's Disease. Front Neurol. 2017 Feb 27;8:55. doi: 10.3389/fneur.2017.00055. eCollection 2017.
citation: Shalash AS, Hamid E, Elrassas HH, Bedair AS, Abushouk AI, Khamis M, Hashim M, Ahmed NS, Ashour S, Elbalkimy M. Non-Motor Symptoms as Predictors of Quality of Life in Egyptian Patients With Parkinson's Disease: A Cross-Sectional Study Using a Culturally Adapted 39-Item Parkinson's Disease Questionnaire. Front Neurol. 2018 May 24;9:357. doi: 10.3389/fneur.2018.00357. eCollection 2018.
citation: Rosler TW, Salama M, Shalash AS, Khedr EM, El-Tantawy A, Fawi G, El-Motayam A, El-Seidy E, El-Sherif M, El-Gamal M, Moharram M, El-Kattan M, Abdel-Naby M, Ashour S, Muller U, Dempfle A, Kuhlenbaumer G, Hoglinger GU. K-variant BCHE and pesticide exposure: Gene-environment interactions in a case-control study of Parkinson's disease in Egypt. Sci Rep. 2018 Nov 8;8(1):16525. doi: 10.1038/s41598-018-35003-4.