Alzheimer DiseaseNCT03628404
Defining the Genetic Etiology of Alzheimer's Disease in the Faroe Islands
An observational study of Alzheimer Disease and Dementia, run by Faroese Hospital System at 1 site in Faroe Islands.
Trial summary
The investigators established the Faroese Alzheimer's Cohort with the aim to unravel genetic and environmental factors that influence the risk and/or susceptibility of Alzheimers disease (AD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia
- How many people
- 1,000 participants
- Where
- 1 siteFaroe Islands
- Study dates
- 1 Sep 2015to 1 Jan 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a population based study conducted in the Faroe Islands, a small island population with approximately 50.000 inhabitants. Individuals diagnosed with dementia are being recruited from the only Dementia Clinic on the islands. Family members are also recruited. Control subjects are randomly selected from the Faroese Population Registry, matched by sex and age to the cases. Te
Who may be able to join
- diagnosis of dementia (cases)
- Age and gender matched to cases (controls)
- Close relatives to an individual with dementia (family members)
Who cannot join
- No exclusion criteria (cases and family members)
- Sign of dementia assessed by MMSE (controls)
Trial locations and contacts
1 site in 1 country.
Faroe Islands1 site, 1 recruiting
- Recruiting
The Faroses Hospital System
Tórshavn, 100
Maria Skaalum Petersen, PhD, 00298 216695, maria@health.fo
About this study
The investigators established the Faroese Alzheimer's Cohort with the aim to unravel genetic and environmental factors that influence the risk and/or susceptibility of Alzheimers disease (AD). It is believed the Faroese population represents a unique opportunity due to its characteristics as a geographic, environmental and genetic isolate with a homogeneous genetic background and founder effects. It has an 'engaged' population with superbly detailed genealogy going 400 years back, unfettered patient access to health care, traditionally high participation rates in research and low probability of losing subjects to follow-up, and presents a unique opportunity to more readily identify genetic and environmental factors involved in AD.
The specific aims of this project are:
- Enrolment of patients with AD, incl.1st degree family members of selected familial patients and age and gender matched control subjects.
- Detailed genealogical investigation of patients with Alzheimer's disease
- Identify genes influencing risk and/or susceptibility of AD in the Faroese population
Read the detailed description
The aim of the study is to unravel genetic and environmental factors that influence the risk and/or susceptibility of AD. Thus, subjects with AD and family members when there is a strong history of AD are being recruited. Data collection includes a blood sample, clinical phenotype data from hospital records, standardized assessment scales (e.g. Geriatric Depression Scale (GDS), Neuropsychiatric Inventory Questionnaire (NPI-Q), Functional Activities Questionnaire (FAQ-IADL), tests of mental function (Mini Mental State Examination (MMSE) and Addenbrooke's Cognitive Examination (ACE)) and family and lifestyle/environmental questionnaire. Furthermore are control subjects being recruited where data includes a blood sample, MMSE and a lifestyle/environmental questionnaire.
Initial genetic analyses will focus on known genetic risk factors for AD by looking at the most highly associated single nucleotide polymorphisms in loci harboring e.g. apolipoprotein E (APOE)/Translocase Of Outer Mitochondrial Membrane 40 (TOMM40), MAPT, Phosphatidylinositol Binding Clathrin Assembly Protein (PICALM). Subsequent analyses will focus on genome-wide array genotyping of ~ 1.8 million markers, e.g. to accommodate the population structure. Finally, patients with a family history of AD who cannot be explained by the before mentioned analysis will be subject to exome sequencing. Exposure analyses will focus on persistant organic pollutants, e.g. polychlorinated biphenyls (PCBs), perfluorinated alkylated substances (PFAS) and also mercury.
The investigators believe the Faroese population presents a unique opportunity to more readily identify genetic and environmental factors involved in AD due to its characteristics as a geographic, environmental and genetic isolate with a homogeneous genetic background.
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Alzheimer disease, Dementia, Faroe Islands, Isolated population, Environmental exposure
- Medical subject headings
- Alzheimer Disease, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequenom iPLEX genotyping and exome sequencing to identify and characterize genetic contributions to etiology of Alzheimer disease and other dementias
Genetic cause of disease
Measured: At baseline
Secondary outcomes (7)
Influence of polychlorinated biphenyl exposure on the risk of AD
Polychlorinated biphenyls levels measured in serum
Measured: At baseline
Influence of perfluorinated alkylated substance exposure on the risk of AD
Perfluorinated alkylated substances (PFAS) levels measured in serum
Measured: At baseline
Influence of mercury exposure on the risk of AD
Mercury levels measured in blood
Measured: At baseline
MMSE
Mini Mental State Examination
Measured: At baseline
ACE
Addenbrooke's cognitive examination
Measured: At baseline
NPI-Q
The Neuropsychiatric Inventory
Measured: At baseline
FAQ IADL
Functional Activities Questionnaire / Functional Assessment Questionnaire
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Sep 2015
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faroese Hospital System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Skaalum Petersen, Faroese Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628404
- Sponsor's protocol ID
- AD
- Status last verified
- Mar 2022
- First submitted
- 6 Aug 2018
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Genetic Etiology of Alzheimer's Disease in the Faroe Islands
- ClinicalTrials.gov ID
- NCT03628404
- Acronym / sponsor ID
- AD
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Alzheimer disease, Dementia, Faroe Islands, Isolated population, Environmental exposure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Faroese Hospital SystemUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 14 Aug 2018 (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 investigators established the Faroese Alzheimer's Cohort with the aim to unravel genetic and environmental factors that influence the risk and/or susceptibility of Alzheimers disease (AD). It is believed the Faroese population represents a unique opportunity due to its characteristics as a geographic, environmental and genetic isolate with a homogeneous genetic background and founder effects. It has an 'engaged' population with superbly detailed genealogy going 400 years back, unfettered patient access to health care, traditionally high participation rates in research and low probability of losing subjects to follow-up, and presents a unique opportunity to more readily identify genetic and environmental factors involved in AD.
The specific aims of this project are:
- Enrolment of patients with AD, incl.1st degree family members of selected familial patients and age and gender matched control subjects.
- Detailed genealogical investigation of patients with Alzheimer's disease
- Identify genes influencing risk and/or susceptibility of AD in the Faroese population
Detailed description
The aim of the study is to unravel genetic and environmental factors that influence the risk and/or susceptibility of AD. Thus, subjects with AD and family members when there is a strong history of AD are being recruited. Data collection includes a blood sample, clinical phenotype data from hospital records, standardized assessment scales (e.g. Geriatric Depression Scale (GDS), Neuropsychiatric Inventory Questionnaire (NPI-Q), Functional Activities Questionnaire (FAQ-IADL), tests of mental function (Mini Mental State Examination (MMSE) and Addenbrooke's Cognitive Examination (ACE)) and family and lifestyle/environmental questionnaire. Furthermore are control subjects being recruited where data includes a blood sample, MMSE and a lifestyle/environmental questionnaire.
Initial genetic analyses will focus on known genetic risk factors for AD by looking at the most highly associated single nucleotide polymorphisms in loci harboring e.g. apolipoprotein E (APOE)/Translocase Of Outer Mitochondrial Membrane 40 (TOMM40), MAPT, Phosphatidylinositol Binding Clathrin Assembly Protein (PICALM). Subsequent analyses will focus on genome-wide array genotyping of ~ 1.8 million markers, e.g. to accommodate the population structure. Finally, patients with a family history of AD who cannot be explained by the before mentioned analysis will be subject to exome sequencing. Exposure analyses will focus on persistant organic pollutants, e.g. polychlorinated biphenyls (PCBs), perfluorinated alkylated substances (PFAS) and also mercury.
The investigators believe the Faroese population presents a unique opportunity to more readily identify genetic and environmental factors involved in AD due to its characteristics as a geographic, environmental and genetic isolate with a homogeneous genetic background.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a population based study conducted in the Faroe Islands, a small island population with approximately 50.000 inhabitants. Individuals diagnosed with dementia are being recruited from the only Dementia Clinic on the islands. Family members are also recruited. Control subjects are randomly selected from the Faroese Population Registry, matched by sex and age to the cases. Te
Key inclusion criteria (3 listed)
- diagnosis of dementia (cases)
- Age and gender matched to cases (controls)
- Close relatives to an individual with dementia (family members)
Key exclusion criteria (2 listed)
- No exclusion criteria (cases and family members)
- Sign of dementia assessed by MMSE (controls)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sequenom iPLEX genotyping and exome sequencing to identify and characterize genetic contributions to etiology of Alzheimer disease and other dementias
Time frame: At baseline
Genetic cause of disease
7 secondary outcomes
Influence of polychlorinated biphenyl exposure on the risk of AD
Time frame: At baseline
Influence of perfluorinated alkylated substance exposure on the risk of AD
Time frame: At baseline
Influence of mercury exposure on the risk of AD
Time frame: At baseline
MMSE
Time frame: At baseline
ACE
Time frame: At baseline
NPI-Q
Time frame: At baseline
FAQ IADL
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Alzheimer Disease and Dementia, run by Faroese Hospital System at 1 site in Faroe Islands.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Mar 2022. 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 Faroe Islands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Skaalum Petersen, PhD (00298216695, maria@health.fo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequenom iPLEX genotyping and exome sequencing to identify and characterize genetic contributions to etiology of Alzheimer disease and other dementias (time frame: At baseline). 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 17 Mar 2022.