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Not yet recruitingNCT06849414Updated Feb 27, 2025

The Relationship Between Homocysteine and Manifestation of Parkinson's Disease Patients

An observational study in Parkinson's Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-02-27.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
44
Ages
40 Years and older
Sex
All
01

Study 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.
  • 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.

02

Conditions studied

  • Parkinson's Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 44 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
44 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. To investigate the relationship between homocysteine level and motor as well as cognitive manifestation of Parkinson's disease patients

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06849414
Lead sponsor
Assiut University
Responsible party
Shrouk Mohammed Hossam Eldien Abdelmohsen (principle investigator, Assiut University) — Principal investigator
First posted
Feb 27, 2025
Start date
Jun 2025 (estimated)
Primary completion
Jun 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Feb 27, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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