Clinical trial NCT02629640: Enhanced CJD Surveillance in the Older Population
Official title: Enhanced CJD Surveillance in the Older Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prion Disease
Dementia
Keywords: vCJD
prion disease
dementia
old-age
surveillance
brain banking
public health
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: Department of Health, United Kingdom
First posted: 2015-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 4.5 years
Secondary outcomes:
measure: Description of clinical, pathological and epidemiological characteristics of patients with atypical features of dementia in the Lothian population.
timeFrame: 4.5 years
measure: Assessment of the suitability of methods to support an extended system of enhanced CJD surveillance in the rest of the UK.
timeFrame: 4.5 years
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: CJD Research and Surveillance Unit, Western General Hospital
Study officials:
affiliation: University of Edinburgh
name: Anna M Molesworth, PhD
role: PRINCIPAL_INVESTIGATOR
References: