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Completed

NCT Number: NCT02629640

Enhanced CJD Surveillance in the Older Population

The purpose of this study to investigate if cases of Creutzfeldt-Jakob Disease (CJD) and other forms of prion disease are being missed in older adults living within Lothian.

Completed

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Key information

Conditions

Prion Disease Brain Diseases Central Nervous System Diseases Central Nervous System Infections Dementia Infections Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Prion Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CJD Research and Surveillance Unit, Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

About this study

The study involves patients aged 65 years or over who have been seen by a neurologist or psycho-geriatrician and identified as having features that are atypical for the known types of dementia. All patients will be invited to an initial meeting with the research team to discuss the study and, if they agree to participate, for clinical assessment and epidemiological review. Participants will be asked to donate blood or a buccal sample for codon-129 polymorphism genotyping and may be offered a MRI brain scan if no such imaging has been previously undertaken. Participants will also be asked to consider if, in the event of their death, they would donate samples of brain tissue to the Edinburgh Brain Bank for use in this and future research. Telephone follow up will be offered within 1 month of joining the study and at 3 monthly intervals thereafter, with further clinical review offered if deemed appropriate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 65 years or above
  • Patients accessing NHS Lothian neurology and psychogeriatric services
  • Patients who have features atypical for the recognised forms of dementia
  • Appropriate informed consent

Exclusion criteria

  • Patients aged below 65 at time of recruitment
  • Patients diagnosed with a clear alternative demonstrable pathology

Treatment and study plan

Medical history questionnaire

Other

Epidemiological review of past medical/dental history; residential history; occupational history; family history of neurodegenerative disease.

Clinical assessment and review

Other

History of current illness; neurological examination including general appearance, full cognitive assessment and physical examination; MRI research brain scan.

Participant Follow-up

Other

Hospital patient management system; regular telephone contact with patient/representative.

Blood or buccal sample

Other

Codon-129 genotyping; storage for future research.

Post mortem examination

Other

Brain tissue donation to the Edinburgh Brain and Tissue Bank for research,including investigations for evidence of prion disease.

Primary outcomes

  1. Evidence of prion disease pathology in the Lothian population, a description of the associated clinical/pathological and epidemiological features and referral characteristics, and how this compares with other cases of prion disease.

    Time frame: 4.5 years

Secondary outcomes

  1. Description of clinical, pathological and epidemiological characteristics of patients with atypical features of dementia in the Lothian population.

    Time frame: 4.5 years

  2. Assessment of the suitability of methods to support an extended system of enhanced CJD surveillance in the rest of the UK.

    Time frame: 4.5 years

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Department of Health, United Kingdom
  • NHS Lothian

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2015
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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