Actively Recruiting
ANeED Joint Effort 21: eHealth and a PPI Program in Dementia With Lewybodies (DLB)
Led by University of Bergen · Updated on 2023-03-17
100
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
U
University of Bergen
Lead Sponsor
H
Helse Fonna
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of the study is to develop predictive algorithms and digital biomarkers to capture disease fluctuations in (prodromal) dementia with lewybodies (DLB) patients and to improve treatment, diagnosis and prognosis of the study drug Ambroxol, used in the ANeED study. This project is an additional study to the ANeED study, registered at ClinicalTrials.gov under NCT04588285.
CONDITIONS
Official Title
ANeED Joint Effort 21: eHealth and a PPI Program in Dementia With Lewybodies (DLB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female.
- Age 50 to 85 years.
- Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or Mild Cognitive Impairment in DLB (DLB-MCI).
- MMSE score of 15 or higher.
- Able and willing to provide informed consent.
- Capable of complying with all study procedures.
- Willing to provide blood samples for genetic analysis.
- Willing and able to self-administer or have a caregiver administer oral ambroxol medication as scheduled.
- Able to travel to the study site.
- Female participants must be non-childbearing or use accepted contraceptive methods with negative pregnancy tests as applicable.
You will not qualify if you...
- Current treatment with anticoagulants that may prevent safe study completion.
- Participation in another clinical trial or use of investigational products within 30 days prior.
- Exposure to more than three investigational products within 12 months prior.
- Confirmed dysphagia preventing ambroxol administration.
- Significant spinal malformations precluding lumbar puncture.
- Known sensitivity to ambroxol or its excipients.
- Rare hereditary disorders related to galactose intolerance or similar.
- History of substance abuse or alcoholism affecting participation.
- Blood donation within three months prior to study drug.
- Pregnant or breastfeeding women or those not agreeing to birth control.
- Clinically significant or unstable psychiatric, medical, or surgical conditions posing risk or affecting study participation.
- Planned major surgery or treatments interfering with study obligations.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Helse Fonna
Haugesund, Rogaland, Norway, 5528
Actively Recruiting
Research Team
A
Arvid Rongve, PhD
CONTACT
J
Jessica Hubbers, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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