Dementia, Lewy Body
Conditions
Keywords
dementia, lewy, wearable, sensor, digital, device, monitoring, actigraphy
Brief summary
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.
Detailed description
Currently, there is no approved treatment for DLB patients, despite the increasing prevalence of DLB. As disease symptoms fluctuate between days and within-day inpatient clinic visits do not adequately capture the fluctuation in disease symptoms. Therefore there is a need for continuous registration. Additionally as DLB caregivers report a high level of caregiver distress, we extended the study to include caregivers to collect data on caregiver distress. For these reasons, a digital application was developed to report study medicine intake and side effects. Data collection from digital sensors (smartphone, smart watch, movement sensors, an EEG/EOG/ mood sensor and a bedside sleep monitor) register DLB symptoms continuously. To be eligible to participate in ANeED Joint Effort 21, patients and their caregivers need to be included in the ANeED study. There will be no additional inpatient clinic visits in ANeED Joint Effort 21, as measurements in between the visits are performed in-home. These measurements include cognitive tests on the smartphone and health data gathered by a smartwatch. Additionally, 2 wearable movement sensors will measure activity and sleep, a bedside sleep monitor that registers sleep disturbances, as well as an EEG-EOG-mood sensor for a duration of one week.
Interventions
DEVICEDigital biomarkers
Digital application Smartwatch Sleep monitor Movement sensor EEG-sensor
Sponsors
Helse Fonna
Helse Stavanger HF
University Hospital, Akershus
Ullevaal University Hospital
Haraldsplass Deaconess Hospital
St. Olavs Hospital
University of Bergen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
A patient is eligible when all inclusion criteria and none of the
Exclusion criteria
are fullfilled in the ANeED study: 1. Male or female. 2. Age ≥ 50 and ≤ 85 years of age. 3. Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or Mild Cognitive Impairment in DLB (DLB-MCI). 4. MMSE score\>=15 5. Able and willing to provide informed consent prior to any study related assessments and procedures at screening visit 1. 6. Capable of complying with all study procedures. 7. Willing to provide blood samples for genetic analyses of APOE and GBA. 8. Willing and able to self-administer or administer by a caregiver oral ambroxol medication, from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)). 9. Able to travel to the participating study site. 10. A female participant is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 consecutive months of spontaneous amenorrhea, at least 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation. In questionable cases, menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 25.8 - 134.8 IU/L and oestradiol \< 201 pmol/l at entry. Women of child-bearing potential must use accepted contraceptive methods (listed below), and must have a negative serum at screening visit 1 and urine pregnancy tests at subsequent visits if applicable. An additional pregnancy test will be performed, and results obtained, prior to administration of the first dose of ambroxol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Digital biomarkers for diagnostic support and medication efficacy | All patient visits from start to 18 months (end of treatment). |
Countries
Norway
Contacts
Primary ContactArvid Rongve, PhD
Backup ContactJessica Hubbers, MSc
Outcome results
None listed