Novel Diagnostic and Disease Stage Biomarkers in AD

Recruiting

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Neuro-Degenerative Diseases; Vascular Dementia; Dementia With Lewy Bodies; Healthy Controls

• Registration Number: NCT05175664
• Lead Sponsor: Danish Dementia Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-1
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Longitudinal study:<br><br> <br><br> - MCI due to AD, or mild or moderate AD dementia according to the National<br> Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria<br><br> - Caregiver willing to participate as an informant<br><br> - MMSE >19 at inclusion<br><br> - Brain FDG-PET/MRI or FDG/PET-CT<br><br> - Able to cooperate to the investigations and give informed consent<br><br> Exclusion criteria:<br><br> - Other neurological or psychiatric illness that may affect neurofilament light<br> (NfL) levels (severe neuropathy, multiple sclerosis (MS), stroke within the<br> last 3 months, Wernicke encephalopathy)<br><br> - Diagnosis of previous or current major psychiatric disorder (schizophrenia,<br> bipolar disorder, psychosis) within last 2 years<br><br> - Excessive alcohol intake or substance abuse within the last 2 years<br><br> - Ophthalmological disorders that may affect pupillometry<br><br> - Participating in drug trials or other intervention trials<br><br> 2. Short-term study:<br><br> <br><br> - Patients under investigation of a neurodegenerative disease<br><br> - MMSE >19<br><br> - Scheduled lumbar puncture/lumbar puncture performed within the last week prior<br> to inclusion<br><br> - Written consent form to the Danish Dementia Biobank<br><br> - Able to cooperate to the investigations<br><br> Exclusion criteria:<br><br> - Other neurological or psychiatric illness that may affect NfL levels (severe<br> neuropathy, MS, stroke within the last 3 months, Wernicke encephalopathy)<br><br> - Excessive alcohol intake or substance abuse within the last 2 years<br><br> - Ophthalmological disorders that may affect pupillometry<br><br> - Participating in drug trials or other intervention trials<br><br> 3. Cross-sectional study:<br><br>Inclusion criteria - Patients:<br><br> - A diagnosis of a dementia disorder<br><br> - Caregiver willing to participate as an informant<br><br> - MMSE >15 at inclusion<br><br> - Able to cooperate to the investigations<br><br> - Able to give informed consent<br><br>Exclusion criteria - Patients:<br><br> - Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar<br> disorder, psychosis) within last 2 years<br><br> - Excessive alcohol intake or substance abuse within the last 2 years<br><br> - Other known brain disorder<br><br> - Ophthalmological disorders that may affect pupillometry<br><br> - Participating in drug trials or other intervention trials<br><br>Inclusion criteria - Healthy Controls:<br><br> - Able to cooperate to the investigations<br><br> - Normal cognition<br><br> - Age 50-90 year<br><br>Exclusion criteria - Healthy Controls:<br><br> - Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar<br> disorder, psychosis) within last 2 years<br><br> - Excessive alcohol intake or substance abuse within the last 2 years<br><br> - Other known brain disorder<br><br> - Ophthalmological disorders that may affect pupillometry

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in CDR

Secondary Outcome Measures

Name	Time	Method
Changes in MMSE;Changes in MR brain scan;FDG-PET brain scan