NCT03628404

Brief 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). 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:

  1. 1.Enrolment of patients with AD, incl.1st degree family members of selected familial patients and age and gender matched control subjects.
  2. 2.Detailed genealogical investigation of patients with Alzheimer's disease
  3. 3.Identify genes influencing risk and/or susceptibility of AD in the Faroese population

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

9.3 years

First QC Date

August 6, 2018

Last Update Submit

March 15, 2022

Conditions

Keywords

Alzheimer diseaseDementiaFaroe IslandsIsolated populationEnvironmental exposure

Outcome Measures

Primary Outcomes (1)

  • Sequenom iPLEX genotyping and exome sequencing to identify and characterize genetic contributions to etiology of Alzheimer disease and other dementias

    Genetic cause of disease

    At baseline

Secondary Outcomes (7)

  • Influence of polychlorinated biphenyl exposure on the risk of AD

    At baseline

  • Influence of perfluorinated alkylated substance exposure on the risk of AD

    At baseline

  • Influence of mercury exposure on the risk of AD

    At baseline

  • MMSE

    At baseline

  • ACE

    At baseline

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • diagnosis of dementia (cases)
  • Age and gender matched to cases (controls)
  • Close relatives to an individual with dementia (family members)

You may not qualify if:

  • Sign of dementia assessed by MMSE (controls)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Faroses Hospital System

Tórshavn, 100, Faroe Islands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma and buffy coat

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Maria Skaalum Petersen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 14, 2018

Study Start

September 1, 2015

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

March 17, 2022

Record last verified: 2022-03

Locations