Novel Diagnostic and Disease Stage Biomarkers in AD

NCT05175664 | Completed

• 1 other identifier: H-21040317
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the efficacy of novel biomarkers, namely blood-based biomarkers, pupillometry and actigraphy to track and predict progression of Alzheimer's disease (AD). Furthermore, the study will investigate the diagnostic value of pupillometry and actigraphy for AD.

Conditions

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

Keywords

Biomarkers; Pupillometry; Actigraphy; Blood-based biomarkers

Outcome Measures

Primary Outcomes (1)

• Changes in CDR

  Clinical Dementia Rating (CDR), a clinical tool for grading the relative severity of dementia with scores ranging from 0 (no impairment) to 3 (severe impairment).

  Two years

Secondary Outcomes (3)

• Changes in MMSE

  Two years

• Changes in MR brain scan

  12 months

• FDG-PET brain scan

  12 months

Study Arms (8)

MCI

Patients suffering from mild cognitive impairment (MCI) due to Alzheimer's disease.

Other: Long-term study

AD

Patients diagnosed with mild to moderate Alzheimer's disease (AD)

Other: Long-term study; Other: Cross-sectional study

NDD

Patients under investigation of a neurodegenerative disease (NDD)

Other: Short-term study

DLB

Patients diagnosed with Dementia with Lewy Bodies (DLB)

Other: Cross-sectional study

VaD

Patients with vascular dementia (VaD)

Other: Cross-sectional study

FTD

Frontotemporal dementia (FTD)

Other: Cross-sectional study

NPH

Normal pressure hydrocephalus (NPH)

Other: Cross-sectional study

Healthy Controls

Healthy Controls without brain disease

Other: Cross-sectional study

Interventions

Long-term study OTHER

No intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan.

AD; MCI

Short-term study OTHER

No intervention. Investigations: blood samples and pupillometry.

NDD

Cross-sectional study OTHER

No intervention. Investigations: cognitive tests, pupillometry and actigraphy.

AD; DLB; FTD; Healthy Controls; NPH; VaD

Eligibility Criteria

• Age: 30 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the longitudinal study (1) the investigators will include 100 patients diagnosed with mild cognitive impairment due to Alzheimer's disease or diagnosed with mild to moderate Alzheimer's disease. In the short-term study (2) the investigators will include 40 patients who are under investigation of a neurodegenerative disease. In the cross-sectional study (3) the investigatorswill include 50 patients with Alzheimer's disease, 50 healthy controls without brain disease, and 100 patients with other forms of dementia (dementia with Lewy body, vascular dementia, normal pressure hydrocephalus, frontotemporal dementia).

You may qualify if:

• MCI due to AD, or mild or moderate AD dementia according to the National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria
• Caregiver willing to participate as an informant
• Brain FDG-PET/MRI or FDG/PET-CT
• Able to cooperate to the investigations and give informed consent

You may not qualify if:

• Other neurological or psychiatric illness that may affect neurofilament light (NfL) levels (severe neuropathy, multiple sclerosis (MS), stroke within the last 3 months, Wernicke encephalopathy)
• Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) within last 2 years
• Excessive alcohol intake or substance abuse within the last 2 years
• Ophthalmological disorders that may affect pupillometry
• Participating in drug trials or other intervention trials
• Short-term study:
• Patients under investigation of a neurodegenerative disease
• MMSE \>19
• Written consent form to the Danish Dementia Biobank
• Able to cooperate to the investigations
• Other neurological or psychiatric illness that may affect NfL levels (severe neuropathy, MS, stroke within the last 3 months, Wernicke encephalopathy)
• Excessive alcohol intake or substance abuse within the last 2 years
• Ophthalmological disorders that may affect pupillometry
• Participating in drug trials or other intervention trials
• Cross-sectional study:

Sponsors & Collaborators

• Danish Dementia Research Centre: lead

Study Sites (1)

Danish Dementia Research Centre

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Clemmensen FK, Gramkow MH, Simonsen AH, Ashton NJ, Huber H, Blennow K, Zetterberg H, Waldemar G, Hasselbalch SG, Frederiksen KS. Short-term variability of Alzheimer's disease plasma biomarkers in a mixed memory clinic cohort. Alzheimers Res Ther. 2025 Jan 21;17(1):26. doi: 10.1186/s13195-024-01658-7.

  PMID: 39838483 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood: A total of 12 mL of blood will be collected at the study visits. Afterwards, the blood will be centrifuged and the serum, plasma and the white blood cells will be extracted. These samples will be stored in the Danish Dementia Biobank prior to analyses.

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia, Vascular; Lewy Body Disease

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Frederikke Kragh Clemmensen, MD

  Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Mathias Holsey Gramkow, MD

  Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Kristian Steen Frederiksen, MD, PhD

  Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Steen Gregers Hasselbalch, DMSc

  Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Anja Hviid Simonsen, MSc Pharm PhD

  Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 4, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)