Enhanced CJD Surveillance in the Older Population
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02629640|
Recruitment Status : Recruiting
First Posted : December 14, 2015
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment|
|Prion Disease Dementia||Other: Medical history questionnaire Other: Clinical assessment and review Other: Participant follow-up Other: Blood or buccal sample Other: Post mortem examination|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Enhanced CJD Surveillance in the Older Population|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
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.
- 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 ]
- Description of clinical, pathological and epidemiological characteristics of patients with atypical features of dementia in the Lothian population. [ Time Frame: 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 ]
Biospecimen Retention: Samples With DNA
- Blood samples
- Buccal samples
- Brain tissue
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629640
|Contact: Audrey Kuchnowski, PgCert||0131 537 1980 ext 32345||Audrey.Kuchnowski@ed.ac.uk|
|CJD Research and Surveillance Unit, Western General Hospital||Recruiting|
|Edinburgh, United Kingdom, EH4 2XU|
|Contact: Audrey Kuchnowski, PgCert 0131 537 1980 Audrey.Kuchnowski@ed.ac.uk|
|Principal Investigator:||Anna M Molesworth, PhD||University of Edinburgh|