Clinical Trials Logo

Clinical Trial Summary

Alzheimer's disease (AD) may currently be diagnosed using molecular biomarkers in cerebrospinal fluid and/or positron emission tomography (PET). These diagnostic procedures are highly accurate, but the high cost and low availability hamper their feasibility. Recently, ultrasensitive blood tests predicting Alzheimer pathologies in the brain have been developed. These tests have a reliable ability to differentiate AD from other neurodegenerative disorders and identify AD across the clinical continuum with high sensitivity and specificity in research cohorts with a high prevalence of AD. This project will assess the predictive value of these tests in a general practice population. Our hypothesis is that the actual blood panel will have high positive predictive value for a diagnosis of Alzheimer's disease in the primary health care setting.

Clinical Trial Description

A correct diagnosis of dementia is important in order to provide the patient and relatives with right information, and to give adequate treatment and support, but also to improve research and further development of treatment. Alzheimer's disease (AD) is the cause of nearly 2/3 of cases of dementia. Current diagnostic methods to ensure accurate diagnosis include analysis of cerebrospinal fluid and molecular PET, but these methods are not widely available and expensive. Progress has been made in the development of blood-based diagnostic biomarkers for Alzheimer's disease. It will lead to significant simplification and improvement of clinical practice if simple blood tests that can be taken in general practice can provide a reliable diagnosis of Alzheimer's disease. Several biomarkers (including phosphorylated tau 181, phosphorylated tau 217, phosphorylated tau 231, plasma glial fibrillary acidic protein, plasma β-amyloid 42 to β-amyloid 40 ratio, and plasma neurofilament light) has documented to be useful to distinguish Alzheimer's dementia from non-Alzheimer's dementia in research cohorts with a high prevalence of AD. This project aims to analyze the diagnostic ability of such biomarkers in a primary care cohort with a lower prevalence of AD. The Stavanger region in Norway will be the catchment area for recruitment of study participants. The region is geographically distinct with 373,000 inhabitants, 15 municipalities with 320 GPs in 94 clinics, all served by one hospital. Consequently, the region offers unique opportunities for community-wide implementation research. All General Practitioners (GPs) in the region will be invited to, upon consent, select participants for the study. To reflect real-life medical practice in primary care we have chosen broad inclusion criteria. Blood samples will be taken at the GP offices. First, we will study the robustness of the samples regarding temperature, time and transportation to the laboratory. Second, we will compare the results of the blood samples with the results of standard diagnostic procedures at the memory outpatient clinic at the hospital. A random sample of an equal number of patients with positive and negative blood biomarker test-results will undergo blinded specialist examination, including MRIs of the brain and analysis of the cerebrospinal fluid for Alzheimer biomarkers. The diagnosis made by the specialists will then be compared to the blood-test results in order to estimate the positive and negative predictive value of such biomarkers for the diagnosis of AD in general practice. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05187819
Study type Interventional
Source Helse Stavanger HF
Contact Svein R Kjosavik, MD PhD
Phone +4790414252
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 15, 2022
Completion date December 31, 2029

See also
  Status Clinical Trial Phase
Completed NCT03378245 - Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations N/A
Recruiting NCT04871698 - On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs
Recruiting NCT04863859 - Persons With Dementia and Their Extended Family Caregivers
Active, not recruiting NCT03631069 - Detecting Dementia in the Retina Using Optical Coherence Tomography
Terminated NCT03682874 - Identifying Novel Aging Targets for Treatment of Delirium
Recruiting NCT03907748 - Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia N/A
Active, not recruiting NCT04058886 - Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers N/A
Recruiting NCT04308512 - Care Coordination System for People With Dementia Phase 1/Phase 2
Active, not recruiting NCT03943641 - Dementia Risk Prediction Model: Development and Validation
Recruiting NCT03472482 - Optical Coherence Tomography in Cerebral Amyloidosis
Recruiting NCT04313582 - Feasibility of the SmartPrompt for Improving Everyday Function in Dementia N/A
Recruiting NCT04428112 - Rural Dementia Caregiver Project N/A
Completed NCT04462029 - A Study to Compare the Pharmacokinetics of BR4002 and BR4002-1 in Healthy Volunteers Early Phase 1
Recruiting NCT03672279 - Validation of a Novel Self-Administered Cognitive Assessment Tool (CogCheck) in Patients With Mild and Major Neurocognitive Disorder Predominantly Due to Alzheimer's Disease
Enrolling by invitation NCT04948866 - Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers N/A
Completed NCT03597360 - Low Dose Ionizing Radiation Using CT Scans as a Potential Therapy for Alzheimer's Dementia: A Pilot Study N/A
Recruiting NCT04645017 - Assessing an Intergenerational Music Program Delivered by Adolescents to Older Adults With Declining Cognition N/A
Recruiting NCT04073225 - Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury N/A
Recruiting NCT04315337 - Improving Everyday Task Performance Through Repeated Practice in Virtual Reality. N/A
Not yet recruiting NCT05165186 - Care Planning for a Loved One With Dementia: Knowledge, Preparing for Decisions, and Emotions N/A