Parkinson DiseasePDPROG-EGYNCT04062279
Predictors of Parkinson's Disease Progression
An observational study of Parkinson Disease and Cognitive Dysfunction, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Cognitive Dysfunction, Biomarkers
- What is being tested?
- serum alpha synuclein autoantibodies, motor and non motor scales
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2019to 1 Oct 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All idiopathic Parkinson patients attending movement disorder clinic meeting the inclusion criteria.
Who may be able to join
- • 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Eman Hamed, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Univeristy
Cairo, 11591
Ali Shalash, Professor, 00201111124815, ali-NEURO@YAHOO.COM
AHMED GABER, PROFESSOR, gabarotus@gmail.com
About this study
Official title: 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
Read the 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:
- Comprehensive medical history and neurological examination.
- 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).
- 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.
- 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.
- Conditions
- Parkinson Disease, Cognitive Dysfunction, Biomarkers
- Being tested
- serum alpha synuclein autoantibodies, motor and non motor scales
- Keywords
- Parkinson's disease, cognitive dysfunction, alpha synuclein, autoantibodies, progression
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, Parkinson Disease 4, Autosomal Dominant Lewy Body, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum alpha synuclein autoantibodies, motor and non motor scalesDiagnostic test
measuring serum alpha synuclein autoantibodies by ELIZA at baseline assessment
| Study group | Role | What they receive |
|---|---|---|
| case group | patients diagnosed with idiopathic paaarkinson's disease according to the clinical criteria. Receives: Diagnostic Test: serum alpha synuclein autoantibodies, motor and non motor scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 1, 2,3 years follow ups
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)
Measured: at 1, 2 ,3 years follow-ups
Secondary outcomes (3)
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)]
Measured: at 1,2, and 3 years
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.
Measured: at1,2, and 3 years
change of quality of life
The Arabic version of Parkinson's Disease Questionnaire (PDQ-39), Higher values represent better outcome.
Measured: at 1, 2 ,3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start15 Nov 2019
- Primary completion30 Apr 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Shalash, Ain Shams University
- Investigators
- Ali Shalash, professor, Principal investigator, Ain Shams Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062279
- Sponsor's protocol ID
- R58/2018
- Acronym
- PDPROG-EGY
- Status last verified
- Mar 2023
- First submitted
- 2 Jul 2019
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29742117Shalash 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.
PubMed 29312137Shalash 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.
PubMed 28289399Shalash 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.
PubMed 29881368Rosler 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.
PubMed 30410011
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Parkinson's Disease Progression in Sample of Egyptian Patients; Clinical and Biochemical
- ClinicalTrials.gov ID
- NCT04062279
- Acronym / sponsor ID
- PDPROG-EGY / R58/2018
- Conditions
- Parkinson Disease, Cognitive Dysfunction, Biomarkers
- Keywords
- Parkinson's disease, cognitive dysfunction, alpha synuclein, autoantibodies, progression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Comprehensive medical history and neurological examination.
- 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).
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: serum alpha synuclein autoantibodies, motor and non motor scalespatients diagnosed with idiopathic paaarkinson's disease according to the clinical criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All idiopathic Parkinson patients attending movement disorder clinic meeting the inclusion criteria.
Key inclusion criteria (2 listed)
- • All are Arabic-speaking individuals diagnosed with PD by a movement disorder neurologist based on the UK bank criteria for idiopathic Parkinson's disease.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum alpha synuclein autoantibodies, motor and non motor scalesmeasuring serum alpha synuclein autoantibodies by ELIZA at baseline assessment | Diagnostic test | case group |
Primary outcome
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
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)
3 secondary outcomes
development of drug (levodopa) complications
Time frame: at 1,2, and 3 years
development of gait problems
Time frame: at1,2, and 3 years
change of quality of life
Time frame: at 1, 2 ,3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 29742117Salama 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.
- Background: PubMed 29312137Shalash 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.
- Background: PubMed 28289399Shalash 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.
- Results publication: PubMed 29881368Shalash 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.
- Results publication: PubMed 30410011Rosler 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Hamed, lecturer contact
Ali Shalash, professor principal investigator
Ain Shams Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Cognitive Dysfunction, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali S Shalash, Professor (+201111124815, ali_neuro@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictors of progression of motor features of PD (time frame: at 1, 2,3 years follow ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04062279, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.