Parkinson Disease Clinical Trial
— PDPROG-EGYOfficial title:
Predictors of Parkinson's Disease Progression in Sample of Egyptian Patients; Clinical and Biochemical
NCT number | NCT04062279 |
Other study ID # | R58/2018 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 15, 2019 |
Est. completion date | October 1, 2024 |
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
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 1, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams Univeristy | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
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: — View 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. — View 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. — View 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 Ad — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | frequency of dementia and mild cognitive impairment in PD patients | 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 | |
Primary | predictors of progression of motor features of PD | 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 | |
Primary | predictors of progression of non motor features of PD | 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 | development of drug (levodopa) complications | 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 | |
Secondary | development of gait problems | 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 | |
Secondary | change of quality of life | The Arabic version of Parkinson's Disease Questionnaire (PDQ-39), Higher values represent better outcome. | at 1, 2 ,3 years |
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