Parkinson's DiseaseNCT06849414
The Relationship Between Homocysteine and Manifestation of Parkinson's Disease Patients
An observational study of Parkinson's Disease, run by Assiut University.
Trial summary
The aim of the current study is to investigate the association between blood homocysteine level and motor as well as cognitive manifestation of PD patients in Assiut governorate. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 44 population divided into 22 control and 22 PD patients Informed written consent will be obtained from all participants after explaining the aim of the study to them, and the study will be approved by the ethical committee of our institution
Who may be able to join
- 1-Inpatients or outpatients from the clinic of movement disorders of neuropsychiatry hospital of Assiut university 2-The age group of the patients is those above 40 years
Who cannot join
- 1-Secondary parkinsonism associated with specific causes such as infections, medication-induced, poisoning, cerebral arteriosclerosis, and trauma 2-Parkinsonism accompanied by other neurodegenerative disease ( specifically multiple syste atrophy, progressive supranuclear palsy, and dementia with Lewy bodies).
- 3-Presence of significant memory or cognitive decline preceding the onset of PD symptoms, as reported by both the patient and/or family members 4-Significant intracranial lesions detected on brain MRI 5-Unable to cooperate in completing the clinical scale assessment and blood sample collection.
- 6-Recent or current use of medications such as antiepileptic drugs and certain chemotherapy drugs that can impact blood Hcy levels or the presence of thyroid dysfunction or renal insufficiency that affects Hcy metabolism.
About this study
Official title: The Relationship Between Blood Homocysteine Level and Motor and Cognitive Manifestation of Parkinson's Disease Patients
- The aim of the current study is to investigate the association between blood homocysteine level and motor as well as cognitive manifestation of PD patients in Assiut governorate.
- Secondary goal is to investigate the association between levels of serum ferritin, iron as well as acute phase proteins (fibrinogen, D-dimer, CRP) and manifestation of PD.
Read the detailed description
Parkinson's disease (PD) is a common progressive neurodegenerative disease which severely affect the quality of life.It was first described by James Parkinson in 1817 as the most prevalent movement disorder and the second most common neurodegenerative disease after Alzheimer's disease (AD).
The etiology of PD remains largely elusive, and the majority of PD cases are of unknown cause.
Homocysteine is included in the pathogenesis of neurodegenerative diseases including PD. Also, patients with hyperhomocysteinemia are more prone to depression and cognitive impairment .Homocysteine is implicated in neurodegenerative diseases via inflammatory response and oxidative stress.
Several studies indicated that iron metabolism is dysregulated in PD. An important fact is the iron loading in dopaminergic neurons of the substantia nigra pars compacta (SNc), which are the cells primarily affected in PD leading to increased neuronal iron and iron-mediated reactive oxygen species (ROS) generation .
Increased Hcy level can facilitate pathological aggregation of proteins involved in neurodegenerative disorders and be toxic to dopaminergic neurons as α synuclein. Homocysteine can modify α synuclein to form more toxic fibrils that are resistant to digestion by proteinases and exhibit propagation activity.
D-dimer serve as risk factor for development of deep venous thrombosis (DVT) in patients with early PD.
Fibrinogen play a role in exacerbating the neuropathological features of neurodegenerative diseases such as PD through regulating pathophysiological mechanisms and signaling pathways while depletion of fibrinogen helps to ameliorate cognitive function impairment in those patients.
- Conditions
- Parkinson's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1-First group will include the control group (22) 2- Second group will include PD patients | 22 people will be included in the control group who don't have PD and 22 patients with PD will be enrolled from the clinic of movement disorders of neuropsychiatry hospital of Assiut University and divided into early PD less than 3 years and late more than 3 years | |
| 1-First group will include the control group (22) | 2-Second will include PD patients (22) whose will be collected from the clinic of movement disorders of Neuropsychiatry hospital of Assiut University and then divided into :a-early PD less than 3 years b-late PD more than 3 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the relationship between homocysteine level and motor as well as cognitive manifestation of Parkinson's disease patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrouk Mohammed Hossam Eldien Abdelmohsen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849414
- Sponsor's protocol ID
- Homocysteine in PD
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Blood Homocysteine Level and Motor and Cognitive Manifestation of Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT06849414
- Acronym / sponsor ID
- Homocysteine in PD
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 27 Feb 2025 (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.
- The aim of the current study is to investigate the association between blood homocysteine level and motor as well as cognitive manifestation of PD patients in Assiut governorate.
- Secondary goal is to investigate the association between levels of serum ferritin, iron as well as acute phase proteins (fibrinogen, D-dimer, CRP) and manifestation of PD.
Detailed description
Parkinson's disease (PD) is a common progressive neurodegenerative disease which severely affect the quality of life.It was first described by James Parkinson in 1817 as the most prevalent movement disorder and the second most common neurodegenerative disease after Alzheimer's disease (AD).
The etiology of PD remains largely elusive, and the majority of PD cases are of unknown cause.
Homocysteine is included in the pathogenesis of neurodegenerative diseases including PD. Also, patients with hyperhomocysteinemia are more prone to depression and cognitive impairment .Homocysteine is implicated in neurodegenerative diseases via inflammatory response and oxidative stress.
Several studies indicated that iron metabolism is dysregulated in PD. An important fact is the iron loading in dopaminergic neurons of the substantia nigra pars compacta (SNc), which are the cells primarily affected in PD leading to increased neuronal iron and iron-mediated reactive oxygen species (ROS) generation .
Increased Hcy level can facilitate pathological aggregation of proteins involved in neurodegenerative disorders and be toxic to dopaminergic neurons as α synuclein. Homocysteine can modify α synuclein to form more toxic fibrils that are resistant to digestion by proteinases and exhibit propagation activity.
D-dimer serve as risk factor for development of deep venous thrombosis (DVT) in patients with early PD.
Fibrinogen play a role in exacerbating the neuropathological features of neurodegenerative diseases such as PD through regulating pathophysiological mechanisms and signaling pathways while depletion of fibrinogen helps to ameliorate cognitive function impairment in those patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-First group will include the control group (22) 2- Second group will include PD patients | – | –22 people will be included in the control group who don't have PD and 22 patients with PD will be enrolled from the clinic of movement disorders of neuropsychiatry hospital of Assiut University and divided into early PD less than 3 years and late more than 3 years |
| 1-First group will include the control group (22) | – | –2-Second will include PD patients (22) whose will be collected from the clinic of movement disorders of Neuropsychiatry hospital of Assiut University and then divided into :a-early PD less than 3 years b-late PD more than 3 years |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 44 population divided into 22 control and 22 PD patients Informed written consent will be obtained from all participants after explaining the aim of the study to them, and the study will be approved by the ethical committee of our institution
Key inclusion criteria (1 listed)
- 1-Inpatients or outpatients from the clinic of movement disorders of neuropsychiatry hospital of Assiut university 2-The age group of the patients is those above 40 years
Key exclusion criteria (3 listed)
- 1-Secondary parkinsonism associated with specific causes such as infections, medication-induced, poisoning, cerebral arteriosclerosis, and trauma 2-Parkinsonism accompanied by other neurodegenerative disease ( specifically multiple syste atrophy, progressive supranuclear palsy, and dementia with Lewy bodies).
- 3-Presence of significant memory or cognitive decline preceding the onset of PD symptoms, as reported by both the patient and/or family members 4-Significant intracranial lesions detected on brain MRI 5-Unable to cooperate in completing the clinical scale assessment and blood sample collection.
- 6-Recent or current use of medications such as antiepileptic drugs and certain chemotherapy drugs that can impact blood Hcy levels or the presence of thyroid dysfunction or renal insufficiency that affects Hcy metabolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the relationship between homocysteine level and motor as well as cognitive manifestation of Parkinson's disease patients
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Assiut University.
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 1 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: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the relationship between homocysteine level and motor as well as cognitive manifestation of Parkinson's disease patients (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2025.