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Status unknownNCT05759403Updated Mar 8, 2023

Comparison Between Parkinson's Disease and Parkinson's Dementia Complex (Genetically,Clinical and Electrophysiological)

An observational study in Parkinson Disease Dementia and Parkinson Disease, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
40
Ages
50 Years to 80 Years
Sex
All
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Study summary

To compare between Idiopathic PD versus Parkinson-Dementia complex using different modalities: Demographic, Clinical, genetic, Psychometric and electrophysiologically

Read the detailed description

Parkinson's disease (PD), is one of the commonest neurodegenerative disorders with a severe progressive course and major impact on patients' quality of life. The development of late-onset PD likely results from the interaction of genetic and environmental factors in the context of brain aging.

Although several environmental exposures have been implicated, evidence for their causal contributions is limited.

PD in Egypt is a rapidly emerging concern as prevalence rose by 40.7% between 1990 and 2016, one of the highest increases in the world. which influences us to dig further in the genetic basis behind the scenes leading to that leap.

Cognitive impairment in PD constitutes a major source of disease burden for patients and families, and has a significant negative effect on patients' quality of life. Cognitive impairment without dementia is designated as mild cognitive impairment of PD (PD-MCI), where the activities of daily living are grossly preserved, whereas dementia associated with PD is designated as PD-D.

Parkinson's disease dementia is a neurofibrillary tangle degeneration involving the deposition of Alzheimer-type tau, predominantly in the mesial temporal cortex, brainstem, and basal ganglia.

The prevalence of Parkinson's Disease Dementia (PD-D) in the general population aged 65 years and over was 0.3 to 0.5%, and 3 to 4% of patients with dementia in the general population were estimated to be due to PD-D.

Transcranial magnetic stimulation (TMS) is a noninvasive neurophysiological technique for assessing human motor cortical function. With TMS, the underlying motor cortex is stimulated by an electric current induced by a transient magnetic field, generated in response to the passage of a large current through the stimulating coil located on the patient's scalp.

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Conditions studied

  • Parkinson Disease Dementia
  • Parkinson Disease
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's planned enrollment of 40 is below the median of 96 across 1,056 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.

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Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients with parkinson's disease and parkinson dementia complex

Inclusion criteria

  • All participants must fulfill the following inclusion criteria of UINTED KINGDOM bank criteria of PD Men or women of at least 50-80 years of age.
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow up.
  • Medically stable outpatients with confirmed diagnosis of idiopathic PD according to United Kingdom Brain Bank Criteria
  • Clear written informed consent from each participant in the trial.
  • Patients after at least 6 h free of parkinsonian drugs (off-state).
  • For the Parkinson's Dementia Complex group, dementia must be evident through history taking or clinical examination

Exclusion criteria

Exclusion Criteria:

  • Pregnants, breastfeeding, or willing to be pregnant during the study.
  • Presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study
  • Participation in any other type of medical research that may interfere with the interpretation of the study.
  • Patients with severe motor disability (bed-ridden ) that may interfere with the study procedure.
  • History of surgical or invasive intervention for Parkinson disease.
  • Patients with history of seizures or epilepsy including history in a first degree relative or patients on treatment that reduce seizure threshold.
  • For the Parkinson's Dementia Complex group, Subject with dementia due to other diseases or with Parkinson's dementia complex and contribution of other disorders (Mixed dementia)
  • Brain imaging suggesting another diagnosis.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with parkinson's disease

    Genetic analysis, clinical data , cortical excitbility

    Diagnostic Test: Cortical excitability using transcranial magnetic stimulation

  • patients with Parkinson dementia complex

    Genetic analysis, clinical data , cortical excitbility

    Diagnostic Test: Cortical excitability using transcranial magnetic stimulation

Interventions

  • Diagnostic testCortical excitability using transcranial magnetic stimulation

    Transcranial magnetic stimulation (TMS) is a noninvasive neurophysiological technique for assessing human motor cortical function. With TMS, the underlying motor cortex is stimulated by an electric current induced by a transient magnetic field, generated in response to the passage of a large current through the stimulating coil located on the patient's scalp.

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What researchers measure

Primary outcomes

  1. Score on MDS-UPDRS

    Score on MDS-UPDRS

    Time frame: through study completion, an average of 1 year

  2. Score on mini mental state examination

    Score on mini mental state examination

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Score on PDQ-39

    Score on PDQ-39

    Time frame: through study completion, an average of 1 year

  2. Score on Score on Montreal Cognitive Assessment

    Score on Score on Montreal Cognitive Assessment

    Time frame: through study completion, an average of 1 year

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Study locations

1 of 1 sites recruiting
  • Assiut university hospital
    Assiut, 12345, Egypt
    Recruiting
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References and documents

Publications

  • Chen H, Ritz B. The Search for Environmental Causes of Parkinson's Disease: Moving Forward. J Parkinsons Dis. 2018;8(s1):S9-S17. doi: 10.3233/JPD-181493. PubMed 30584168 ↗
  • Ball N, Teo WP, Chandra S, Chapman J. Parkinson's Disease and the Environment. Front Neurol. 2019 Mar 19;10:218. doi: 10.3389/fneur.2019.00218. eCollection 2019. PubMed 30941085 ↗
  • Priyadarshi A, Khuder SA, Schaub EA, Priyadarshi SS. Environmental risk factors and Parkinson's disease: a metaanalysis. Environ Res. 2001 Jun;86(2):122-7. doi: 10.1006/enrs.2001.4264. PubMed 11437458 ↗
  • Bellou V, Belbasis L, Tzoulaki I, Evangelou E, Ioannidis JP. Environmental risk factors and Parkinson's disease: An umbrella review of meta-analyses. Parkinsonism Relat Disord. 2016 Feb;23:1-9. doi: 10.1016/j.parkreldis.2015.12.008. Epub 2015 Dec 17. PubMed 26739246 ↗
  • GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14. PubMed 30879893 ↗
  • Sezgin M, Bilgic B, Tinaz S, Emre M. Parkinson's Disease Dementia and Lewy Body Disease. Semin Neurol. 2019 Apr;39(2):274-282. doi: 10.1055/s-0039-1678579. Epub 2019 Mar 29. PubMed 30925619 ↗
  • Morris HR, Steele JC, Crook R, Wavrant-De Vrieze F, Onstead-Cardinale L, Gwinn-Hardy K, Wood NW, Farrer M, Lees AJ, McGeer PL, Siddique T, Hardy J, Perez-Tur J. Genome-wide analysis of the parkinsonism-dementia complex of Guam. Arch Neurol. 2004 Dec;61(12):1889-97. doi: 10.1001/archneur.61.12.1889. PubMed 15596609 ↗
  • Aarsland D, Zaccai J, Brayne C. A systematic review of prevalence studies of dementia in Parkinson's disease. Mov Disord. 2005 Oct;20(10):1255-63. doi: 10.1002/mds.20527. PubMed 16041803 ↗
  • Chen R, Cros D, Curra A, Di Lazzaro V, Lefaucheur JP, Magistris MR, Mills K, Rosler KM, Triggs WJ, Ugawa Y, Ziemann U. The clinical diagnostic utility of transcranial magnetic stimulation: report of an IFCN committee. Clin Neurophysiol. 2008 Mar;119(3):504-532. doi: 10.1016/j.clinph.2007.10.014. Epub 2007 Dec 11. PubMed 18063409 ↗
  • Rossini PM, Barker AT, Berardelli A, Caramia MD, Caruso G, Cracco RQ, Dimitrijevic MR, Hallett M, Katayama Y, Lucking CH, et al. Non-invasive electrical and magnetic stimulation of the brain, spinal cord and roots: basic principles and procedures for routine clinical application. Report of an IFCN committee. Electroencephalogr Clin Neurophysiol. 1994 Aug;91(2):79-92. doi: 10.1016/0013-4694(94)90029-9. No abstract available. PubMed 7519144 ↗
  • Ziemann U, Netz J, Szelenyi A, Homberg V. Spinal and supraspinal mechanisms contribute to the silent period in the contracting soleus muscle after transcranial magnetic stimulation of human motor cortex. Neurosci Lett. 1993 Jun 25;156(1-2):167-71. doi: 10.1016/0304-3940(93)90464-v. PubMed 8414181 ↗
  • Chen R, Lozano AM, Ashby P. Mechanism of the silent period following transcranial magnetic stimulation. Evidence from epidural recordings. Exp Brain Res. 1999 Oct;128(4):539-42. doi: 10.1007/s002210050878. PubMed 10541749 ↗
  • Daskalakis ZJ, Christensen BK, Chen R, Fitzgerald PB, Zipursky RB, Kapur S. Evidence for impaired cortical inhibition in schizophrenia using transcranial magnetic stimulation. Arch Gen Psychiatry. 2002 Apr;59(4):347-54. doi: 10.1001/archpsyc.59.4.347. PubMed 11926935 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05759403
Lead sponsor
Assiut University
Responsible party
Eman M. Khedr (Professor doctor, Assiut University) — Principal investigator
First posted
Mar 8, 2023
Start date
Nov 1, 2022
Primary completion
Oct 30, 2023 (estimated)
Completion
Nov 30, 2023 (estimated)
Last update
Mar 8, 2023

Oversight

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

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