The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease (BRIDGE-AD2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 550
- Locations
- 8
- Primary Endpoint
- Time from baseline to final diagnosis
Study Overview
Brief Summary
Cognitive disorders have a broad differential diagnosis, and a precise, timely diagnosis is essential for personalized treatment and care. Currently, dementia diagnoses are often not further specified according to the underlying pathology and are frequently delayed by several years. However, with the upcoming disease-modifying treatments (DMTs) for AD, an accurate, pathology-driven (i.e., etiological) diagnosis will become necessary.
Blood-based biomarkers (BBMs) are promising tools for detecting Alzheimer's disease (AD), with current research showing high concordance with cerebrospinal fluid (CSF) biomarkers and amyloid PET imaging. However, it remains unclear how physicians would value the availability of BBMs for AD in routine clinical practice. The investigators hypothesize that BBMs will benefit both patients and physicians in the diagnostic process within a memory clinic setting.
This study aims to investigate clinical impact and diagnostic utility of blood-based biomarkers for AD in the diagnostic process of a memory clinic. The main objectives are to investigate change in diagnosis, diagnostic certainty and patient management, due to BBM results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient presents in memory clinic with cognitive complaints.
- •The physician is concerned about underlying AD as etiology of the complaints.
- •Adequate fluency in Dutch to understand informed consent procedure.
Exclusion Criteria
- •Age under
- •Previous biomarker-confirmed diagnosis of AD.
- •Alcohol or drug abuse to such an extent that treatment would be advisable.
- •Patient is incapacitated, and is not able to judge consequences of participation.
Outcomes
Primary Outcomes
Time from baseline to final diagnosis
Time Frame: From enrolment to final diagnosis, assessed up to 100 months
The time from baseline visit to final diagnosis will be reported in days.
Change in diagnosis
Time Frame: From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months
Comparison between the diagnosis (syndrome diagnosis and etiology) before and after BBM testing. Change in diagnosis will be reported as yes/no.
Change in physician's confidence in diagnosis
Time Frame: From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months
Comparison between physician's confidence in diagnosis before and after BBM testing within the intervention group. Physician's confidence will be measured on a 7-point Likert scale, with 1 being very uncertain and 7 being very certain.
Secondary Outcomes
- Difference between the intervention group and the control group in use and timing of ancillary tests(From enrolment to final diagnosis, assessed up to 100 months)
- Concordance of BBM results with the presence of AD pathology according to CSF or amyloid PET(From enrolment to final diagnosis, assessed up to 100 months)
- Difference between the intervention group and the control group in patient management: follow-up duration(From enrolment to final diagnosis, assessed up to 100 months)
- Difference between the intervention group and the control group in patient management: referral(From enrolment to final diagnosis, assessed up to 100 months)
- Difference between the intervention group and the control group in patient management: prescription of medication(From enrolment to final diagnosis, assessed up to 100 months)
Investigators
Floor Duits
Dr.
Alzheimercentrum Amsterdam