Research Group for Age Related Medicine

Lewy Body Dementia (LBD) is a common but often underdiagnosed and misdiagnosed condition within the spectrum of dementia, characterized by symptoms that differ from other dementia disorders. A hallmark of this disease is the fluctuation of symptoms, meaning individuals may experience fewer symptoms on some days and more pronounced symptoms on others.

Common symptoms include REM sleep behaviour disorder, visual hallucinations, delusions, impaired memory, slowed movements, and stiffness in the arms and legs.

Currently, there is no treatment that slows or cures this disease. This study aims to advance the search for such a treatment by investigating the effects of the cough medication Ambroxol on the disease and its symptoms.

The study is a national initiative conducted at eight sites across the country, coordinated from Haugesund. It is a randomized, double-blind, placebo-controlled trial (RCT), meaning participants are divided into two groups—half receiving the medication Ambroxol and the other half receiving placebo tablets. Neither the participants nor the treating clinicians know which group the participant is assigned to until the study concludes or in cases where the participant enrolls in the ANeED Open Label phase.

In emergencies, unblinding is possible, meaning we can determine whether a participant has been receiving the actual medication or not.
Participation in the study involves various assessments throughout the 18-month duration, with a concentration of tests at the start and end of the study. Initial and concluding assessments include:

• Lumbar puncture to collect cerebrospinal fluid
• MRI, DaTSCAN, and EEG of the brain
• ECG of the heart
• Blood tests
• Clinical and neurological examinations
• Cognitive tests

During the study, participants will undergo regular ECGs, blood tests, clinical and neurological exams, and cognitive testing. Contact is maintained approximately monthly, with in-person visits to the hospital about every three months.

The frequency of visits and contact is higher at the beginning of the study to ensure a thorough understanding of the participant’s condition and to provide closer follow-up during the medication initiation phase.

Participation in the ANeED study can be combined with participation in the NorDLB study.

Lewy Body Dementia (DLB) is challenging to diagnose, particularly in women, and a recent genome-wide association study may shed light on why this is the case: women and men have different genetic risk factors for the disease. This could explain why DLB is less common in women and why the clinical presentation in women more closely resembles Alzheimer’s disease, increasing the likelihood of misdiagnosing DLB as Alzheimer’s in women.

Underdiagnosis and misdiagnosis are common among individuals living with DLB, especially women. Clinicians therefore require objective biomarkers to aid in the early diagnosis of DLB.

In this project, we aim to investigate the effects of various DLB risk genes on novel biomarkers in blood and cerebrospinal fluid in women compared to men. Additionally, we will explore gender differences in treatment effects among individuals with DLB treated with Ambroxol in a clinical drug trial.

This is an add-on study to the ANeED study, conducted in collaboration with the University of Bergen, Western Norway University of Applied Sciences, the Regional Competence Centre for Age Related Medicine at Stavanger University Hospital, and private partners.

The study aims to identify digital biomarkers for the disease and potential treatment effects from Ambroxol, as well as to explore how the disease impacts caregivers and identify measures to improve participant recruitment for the drug trial. A program will be developed to reduce stress in close family caregivers.

The sensors used in the study include smartphones with a custom-developed app, a smartwatch, motion sensors (one for the wrist and one for the lower back), and a sleep monitor. The smartphone and smartwatch will be used throughout the entire ANeED study.

The other sensors will be used for one week continuously, a total of four times for each patient. If family caregivers participate, the sensors will be used for one week continuously, but only once.

After participating in the ANeED study, the participants are offered to participate in the ANeED Open Label.

It is a continuation study where all participants are offered treatment with Ambroksol for 12 months. The frequency and content of the visits and telephone contact are the same as in the main study.

Alzheimer’s disease is the most common and well-known form of dementia, affecting many individuals and their families.

This clinical trial aims to investigate the effects of the drug Fasudil on the disease and its symptoms.

The study began in spring 2024 and is led by Stavanger University Hospital, with plans to expand to additional sites nationwide.

It is a randomized, double-blind, controlled trial (RCT), meaning participants are divided into two groups by random allocation. Half of the participants receive the drug Fasudil, while the other half receive placebo tablets. Neither the participants nor the researchers know which group they are in until the study concludes.

In emergency situations, the study team has the option to "unblind," allowing them to determine whether the participant has been receiving the active drug or the placebo.

Participation and Assessments

Participation involves a series of investigations throughout the study, with more extensive assessments at the beginning and end of the 12-month period.

There are a total of 16 study visits over the course of one year.

Initial and final assessments include:

• Lumbar puncture for cerebrospinal fluid sampling
• PET scan of the brain
• Electrocardiogram (ECG)
• Blood and urine tests
• Clinical and neurological examinations
• Cognitive testing

Monthly follow-ups involve:

• Collection of relevant medical history and information
• ECG
• Blood and urine tests
• Clinical and neurological examinations

Memory tests are conducted every three months, while other cognitive tests are administered three times during the study (at baseline, after six months, and at the end of the study).

This is a Norwegian arm of a larger European observational study focusing on dementia with Lewy bodies (DLB), led by Stavanger University Hospital.

The aim of the study is to identify new and improved biomarkers in patients' blood, cerebrospinal fluid (CSF), and imaging tests. These biomarkers are intended to enable a more accurate diagnosis and provide insights into disease progression in individuals with DLB.

Participation Details

Participation involves the collection of biomarkers at the start of the study, including:

• Blood tests
• Lumbar puncture for CSF sampling
• MRI
• DaTSCAN and EEG of the brain
• FDG-PET scan of the brain (optional)

Additionally, the study collects relevant medical history and conducts:

• Clinical and neurological examinations
• Electrocardiogram (ECG) of the heart
• Cognitive tests

Follow-Up

Study visits occur 1-2 times annually for up to five years. Participation in the Nor-DLB study can be combined with the ANeED study.

As part of participation in our studies, we also provide information about donating and storing biological material for research into age-related brain diseases in future studies.

Simply put, you can consent to allow us to collect additional sample tubes when samples are taken (blood, cerebrospinal fluid, urine, and/or saliva). These additional samples will be stored in a biobank located in Stavanger and used for future research projects.

Key Information

• No additional sampling is required beyond what is necessary for the research project you are participating in.
• However, extra sample tubes are collected during the scheduled sampling process.
• If you have consented to allow your samples to be used in new research projects, you will receive a new consent form to review and sign if the ethical committee requires it for the new project.

• Arvid Rongve, Senior Consultant/Geriatric Psychiatrist, and Professor (Cristin profile)
• Luiza Chwiszczuk, Neurologist/Senior Consultant
• Monica Haraldseid Breitve, PhD, Specialist Psychologist
• Mathilde Hemminghyth, PhD-candidate, Neuropsychologist
• Sólveig Birta Vik, Research Nurse
• Lillian Skumsnes, Research Bioengineer
• Heidi Isaksen, PhD Student
• Linnea Borg, Psychologist
  We also work with user representatives who provide valuable feedback to make our research more relevant.

We collaborate with several institutions, including:

• University of Bergen
• SESAM (Regional Competence Center for Age Related Medicine)
• Western Norway University of Applied Sciences
• Helse Vest IKT

The research group is based at Haugesund Hospital on the southwest coast of Norway. You’ll find us on the first floor, just inside the main reception area.

Are you interested in participating in a research project on dementia or aging?

Or are you a caregiver for someone living with dementia who would like to share feedback?

Contact us at ANeED@helse-fonna.no