Dementia, FrontotemporalNCT05911932
Investigating Genetic Status in Patients Presenting to Clinic
An observational study of Dementia, Frontotemporal and Alzheimer Dementia (AD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The causes of neurodegenerative dementias such as Frontotemporal Dementia, Lewy Body Disease and Alzheimer's disease are still largely unknown. While the contribution of some genetic mutations and polymorphisms is associated with autosomal dominant patterns of inheritance of these dementias, in many cases, the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Frontotemporal, Alzheimer Dementia (AD), Lewy Body Dementia (LBD)
- What is being tested?
- Biosample collection.
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2023to Aug 2043
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, AD, FTD, LBD, ALSP, and related conditions); Biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic;
Who may be able to join
- Persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, AD, FTD, LBD, ALSP, and related conditions);
- Biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic;
- Age 18+ years old;
- Consenting to a blood draw.
Who cannot join
- Persons declining / unwilling / not able to have a blood draw.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Parkwood Institute
London, Ontario, N6C 0A7
S Jesso, BA, 519-646-6000
About this study
The causes of neurodegenerative dementias such as Frontotemporal Dementia, Lewy Body Disease and Alzheimer's disease are still largely unknown. While the contribution of some genetic mutations and polymorphisms is associated with autosomal dominant patterns of inheritance of these dementias, in many cases, the specific causative mutation in these families is not yet identified. Further, in many patients, polygenic risk is thought to give rise to pathophysiologic changes, but which specific genes affect risk are largely yet unknown. By examining genotypes in patients that present to our Cognitive Neurology and Alzheimer's Research Clinic with suspected or confirmed neurodegenerative dementia, or have a history of a familial dementia, we aim to help identify and characterize genetic mutations or polymorphisms that give rise to neurodegenerative diseases.
- Being tested
- Biosample collection.
- Keywords
- Neurodegenerative disorders
- Medical subject headings
- Frontotemporal Dementia, Alzheimer Disease, Lewy Body Disease, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosample collection.Other
Blood draw.
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood draw for genetic status or polymorphism result.
The blood draw is taken at the time of the clinic visit. Up to 30ml will be collected by standard venipuncture.
Measured: A one-time visit, taking the participant approximately 20 minutes total for all study procedures.
Secondary outcomes (3)
Demographic information.
Demographic information will be collected at the time of the clinic visit.
Measured: A one-time visit, taking the participant approximately 20 minutes total for all study procedures.
Medical history/Clinical diagnoses.
Will be obtained via chart review when available. This information is collected already as part of the patient's standard care.
Measured: Typically within 1 month of the clinic visit, taking approximately 5 minutes.
Pathological diagnoses.
Will be obtained via chart review when available. This information is collected already as part of the patient's standard care.
Measured: Typically within 1 month of the clinic visit, taking approximately 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start20 Oct 2023
- Primary completionAug 2038 (estimated)
- Study completionAug 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, FrontotemporalStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Finger, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Elizabeth Finger, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911932
- Sponsor's protocol ID
- 121760
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Genetic Status in Patients Presenting to Clinic
- ClinicalTrials.gov ID
- NCT05911932
- Acronym / sponsor ID
- 121760
- Keywords
- Neurodegenerative disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- Aug 2038 (estimated)
- Study completion
- Aug 2043 (estimated)
- First posted
- 22 Jun 2023 (actual)
- 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 causes of neurodegenerative dementias such as Frontotemporal Dementia, Lewy Body Disease and Alzheimer's disease are still largely unknown. While the contribution of some genetic mutations and polymorphisms is associated with autosomal dominant patterns of inheritance of these dementias, in many cases, the specific causative mutation in these families is not yet identified. Further, in many patients, polygenic risk is thought to give rise to pathophysiologic changes, but which specific genes affect risk are largely yet unknown. By examining genotypes in patients that present to our Cognitive Neurology and Alzheimer's Research Clinic with suspected or confirmed neurodegenerative dementia, or have a history of a familial dementia, we aim to help identify and characterize genetic mutations or polymorphisms that give rise to neurodegenerative diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, AD, FTD, LBD, ALSP, and related conditions); Biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic;
Key inclusion criteria (4 listed)
- Persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, AD, FTD, LBD, ALSP, and related conditions);
- Biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic;
- Age 18+ years old;
- Consenting to a blood draw.
Key exclusion criteria (1 listed)
- Persons declining / unwilling / not able to have a blood draw.
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 |
|---|---|---|
| Biosample collection.Blood draw. | Other | – |
Primary outcome
Blood draw for genetic status or polymorphism result.
Time frame: A one-time visit, taking the participant approximately 20 minutes total for all study procedures.
The blood draw is taken at the time of the clinic visit. Up to 30ml will be collected by standard venipuncture.
3 secondary outcomes
Demographic information.
Time frame: A one-time visit, taking the participant approximately 20 minutes total for all study procedures.
Medical history/Clinical diagnoses.
Time frame: Typically within 1 month of the clinic visit, taking approximately 5 minutes.
Pathological diagnoses.
Time frame: Typically within 1 month of the clinic visit, taking approximately 5 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- 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.
Elizabeth Finger, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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 Dementia, Frontotemporal and Alzheimer Dementia (AD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 1 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: looking for participants now, as of the sponsor's last update on 4 Mar 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Jesso (519-646-6000, cognitiveneurology@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood draw for genetic status or polymorphism result. (time frame: A one-time visit, taking the participant approximately 20 minutes total for all study procedures.). 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 4 Mar 2025.