Enhanced CJD Surveillance in the Older Population

NCT02629640 | Completed DMC

• 1 other identifier: 15/SS/0196
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prion Disease; Dementia

Keywords

vCJD; prion disease; dementia; old-age; surveillance; brain banking; public health

Outcome Measures

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.

  4.5 years

Secondary Outcomes (2)

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

  4.5 years

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

  4.5 years

Study Arms (1)

Research Participants

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

Other: Medical history questionnaire; Other: Clinical assessment and review; Other: Participant follow-up; Other: Blood or buccal sample; Other: Post mortem examination

Interventions

Medical history questionnaire OTHER

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

Research Participants

Clinical assessment and review OTHER

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

Research Participants

Participant follow-up OTHER

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

Research Participants

Blood or buccal sample OTHER

Codon-129 genotyping; storage for future research.

Research Participants

Post mortem examination OTHER

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

Research Participants

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65+ accessing NHS Lothian neurology/psychogeriatric services with atypical features of the recognised forms of dementia. Eligible patients will be identified by the local clinical team by screening their existing patient lists, as they see patients as they attend their clinic or are visited in the community. The clinic staff are asked to consult the study team to confirm the patient's eligibility.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator
• Department of Health, United Kingdom: collaborator

Study Sites (1)

CJD Research and Surveillance Unit, Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Blood samples * Buccal samples * Brain tissue

MeSH Terms

Conditions

Prion Diseases; Dementia

Interventions

Blood Specimen Collection; Autopsy

Condition Hierarchy (Ancestors)

Central Nervous System Infections; Infections; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Brain Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anna M Molesworth, PhD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: January 19, 2016
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)