Prion DiseaseNCT02629640
Enhanced CJD Surveillance in the Older Population
An observational study of Prion Disease and Dementia, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Prion Disease, Dementia
- What is being tested?
- Medical history questionnaire, Clinical assessment and review and Participant follow-up
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2016to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients aged below 65 at time of recruitment
- Patients diagnosed with a clear alternative demonstrable pathology
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
CJD Research and Surveillance Unit, Western General Hospital
Edinburgh, EH4 2XU
About this study
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.
Read the 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.
- Conditions
- Prion Disease, Dementia
- Being tested
- Medical history questionnaire, Clinical assessment and review, Participant follow-up, Blood or buccal sample, Post mortem examination
- Keywords
- vCJD, prion disease, dementia, old-age, surveillance, brain banking, public health
- Medical subject headings
- Prion Diseases, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical history questionnaireOther
Epidemiological review of past medical/dental history; residential history; occupational history; family history of neurodegenerative disease.
Clinical assessment and reviewOther
History of current illness; neurological examination including general appearance, full cognitive assessment and physical examination; MRI research brain scan.
Participant follow-upOther
Hospital patient management system; regular telephone contact with patient/representative.
Blood or buccal sampleOther
Codon-129 genotyping; storage for future research.
Post mortem examinationOther
Brain tissue donation to the Edinburgh Brain and Tissue Bank for research,including investigations for evidence of prion disease.
| Study group | Role | What they receive |
|---|---|---|
| Research Participants | Medical history questionnaire; clinical assessment and review; participant follow-up; blood or buccal sample; post mortem examination. Receives: Other: Medical history questionnaire; Other: Clinical assessment and review; Other: Participant follow-up; Other: Blood or buccal sample; Other: Post mortem examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4.5 years
Secondary outcomes (2)
Description of clinical, pathological and epidemiological characteristics of patients with atypical features of dementia in the Lothian population.
Measured: 4.5 years
Assessment of the suitability of methods to support an extended system of enhanced CJD surveillance in the rest of the UK.
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study start19 Jan 2016
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prion DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, Department of Health, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Anna M Molesworth, PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629640
- Sponsor's protocol ID
- 15/SS/0196
- Status last verified
- Jun 2024
- First submitted
- 10 Dec 2015
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced CJD Surveillance in the Older Population
- ClinicalTrials.gov ID
- NCT02629640
- Acronym / sponsor ID
- 15/SS/0196
- Conditions
- Prion Disease, Dementia
- Keywords
- vCJD, prion disease, dementia, old-age, surveillance, brain banking, public health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, Department of Health, United Kingdom
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research Participants | – | Other: Medical history questionnaire, Other: Clinical assessment and review, Other: Participant follow-up, Other: Blood or buccal sample, Other: Post mortem examinationMedical history questionnaire; clinical assessment and review; participant follow-up; blood or buccal sample; post mortem examination. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients aged below 65 at time of recruitment
- Patients diagnosed with a clear alternative demonstrable pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical history questionnaireEpidemiological review of past medical/dental history; residential history; occupational history; family history of neurodegenerative disease. | Other | Research Participants |
| Clinical assessment and reviewHistory of current illness; neurological examination including general appearance, full cognitive assessment and physical examination; MRI research brain scan. | Other | Research Participants |
| Participant follow-upHospital patient management system; regular telephone contact with patient/representative. | Other | Research Participants |
| Blood or buccal sampleCodon-129 genotyping; storage for future research. | Other | Research Participants |
| Post mortem examinationBrain tissue donation to the Edinburgh Brain and Tissue Bank for research,including investigations for evidence of prion disease. | Other | Research Participants |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna M Molesworth, PhD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prion Disease and Dementia, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.