Enhanced CJD Surveillance in the Older Population

NCT ID: NCT02629640

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-19

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prion Disease Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Research Participants

Medical history questionnaire; clinical assessment and review; participant follow-up; blood or buccal sample; post mortem examination.

Medical history questionnaire

Intervention Type OTHER

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

Clinical assessment and review

Intervention Type OTHER

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

Participant follow-up

Intervention Type OTHER

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

Blood or buccal sample

Intervention Type OTHER

Codon-129 genotyping; storage for future research.

Post mortem examination

Intervention Type OTHER

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

Interventions

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Medical history questionnaire

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

Intervention Type OTHER

Clinical assessment and review

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

Intervention Type OTHER

Participant follow-up

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

Intervention Type OTHER

Blood or buccal sample

Codon-129 genotyping; storage for future research.

Intervention Type OTHER

Post mortem examination

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

Department of Health, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna M Molesworth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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CJD Research and Surveillance Unit, Western General Hospital

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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15/SS/0196

Identifier Type: -

Identifier Source: org_study_id

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