NCT06849414

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jun 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Jun 2025Jul 2026

First Submitted

Initial submission to the registry

February 24, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 24, 2025

Last Update Submit

February 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    one year

Study Arms (2)

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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).
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 24, 2025

First Posted

February 27, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 27, 2025

Record last verified: 2025-02