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The Swedish BioFINDER - Preclinical AD Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

This research study aims to examine biomarkers of Alzheimer's disease (AD) as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Skåne University Hospital in Sweden. The study will enroll up to 600 cognitively healthy subjects aged 50 to 80 years with 3/4 having preclinical Alzheimer's disease. Recruitment and enrollment will be ongoing for 2-3 years, and subject participation will be lasting approximately 4 years. Disclosure of AD risk assessments will be an optional procedure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
View:

• Age 50-80

• Individuals aged 50-60 require at least one of the following risk factors for AD:

‣ Known apolipoprotein E (APOE) -ε4 carrier

⁃ Known 1st degree family history of dementia or severe memory loss with onset prior to 75.

⁃ Known amyloid brain pathology by either CSF or PET scan.

• Mini-Mental State Examination (MMSE) ≥26 (aged \>65); MMSE ≥27 (aged 50-65).

• Score of 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version.

• Speaks and understands Swedish to the extent that an interpreter is not necessary to fully understand the study information and cognitive tests.

∙ 6a. Preclinical Alzheimer's disease subgroup (n=450): Amyloid pathology according to cerebrospinal fluid Alzheimer's disease and amyloid PET scans.

∙ 6b. Non-Preclinical Alzheimer's disease subgroup (n=150): No sign of preclinical Alzheimer's disease using cerebrospinal fluid Alzheimer's disease biomarkers or Aβ-PET scans.

Locations
Other Locations
Sweden
Skåne University Hospital
RECRUITING
Malmo
Contact Information
Primary
Erik Stomrud, MD, PhD
erik.stomrud@med.lu.se
+46 40 33 10 00
Backup
Niklas Mattsson-Carlgren, MD, PhD
niklas.mattsson-carlgren@med.lu.se
+46 40 33 10 00
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 800
Treatments
Cognitively unimpaired individuals with preclinical Alzheimer's disease
75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
Cognitively unimpaired individuals without preclinical Alzheimer's disease.
25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
Related Therapeutic Areas
Sponsors
Leads: Skane University Hospital
Collaborators: Lund University

This content was sourced from clinicaltrials.gov