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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. Identifier: NCT02629640
Recruitment Status : Recruiting
First Posted : December 14, 2015
Last Update Posted : August 13, 2018
NHS Lothian
Department of Health, United Kingdom
Information provided by (Responsible Party):
Anna Molesworth, University of Edinburgh

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.

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

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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.

Primary Outcome Measures :
  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. [ Time Frame: 4.5 years ]

Secondary Outcome Measures :
  1. Description of clinical, pathological and epidemiological characteristics of patients with atypical features of dementia in the Lothian population. [ Time Frame: 4.5 years ]
  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02629640

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Contact: Audrey Kuchnowski, PgCert 0131 537 1980 ext 32345

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United Kingdom
CJD Research and Surveillance Unit, Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Audrey Kuchnowski, PgCert    0131 537 1980   
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Department of Health, United Kingdom
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Principal Investigator: Anna M Molesworth, PhD University of Edinburgh

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Responsible Party: Anna Molesworth, Senior Epidemiologist, University of Edinburgh Identifier: NCT02629640     History of Changes
Other Study ID Numbers: 15/SS/0196
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anna Molesworth, University of Edinburgh:
prion disease
brain banking
public health

Additional relevant MeSH terms:
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Prion Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Central Nervous System Infections
Neurodegenerative Diseases