Enhanced CJD Surveillance in the Older Population

August 14, 2019 updated by: Anna Molesworth, University of Edinburgh
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • CJD Research and Surveillance Unit, Western General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Research Participants
Medical history questionnaire; clinical assessment and review; participant follow-up; blood or buccal sample; post mortem examination.
Other: Medical history questionnaire
Epidemiological review of past medical/dental history; residential history; occupational history; family history of neurodegenerative disease.
Other: Clinical assessment and review
History of current illness; neurological examination including general appearance, full cognitive assessment and physical examination; MRI research brain scan.
Other: Participant follow-up
Hospital patient management system; regular telephone contact with patient/representative.
Other: Blood or buccal sample
Codon-129 genotyping; storage for future research.
Other: Post mortem examination
Brain tissue donation to the Edinburgh Brain and Tissue Bank for research,including investigations for evidence of prion disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Description of clinical, pathological and epidemiological characteristics of patients with atypical features of dementia in the Lothian population.
Time Frame: 4.5 years
4.5 years
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
4.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian
Department of Health, United Kingdom

Investigators

  • Principal Investigator: Anna M Molesworth, PhD, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

March 1, 2020

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (ESTIMATE)

December 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/SS/0196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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