Dementia, Lewy BodyJointEffort21NCT05773443
ANeED Joint Effort 21: eHealth and a PPI Program in Dementia With Lewybodies (DLB)
An observational study of Dementia, Lewy Body, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Dementia, Lewy Body
- What is being tested?
- Digital biomarkers
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants already included in ANeED drug trial with willingness to comply to the additional study.
Who may be able to join
- A patient is eligible when all inclusion criteria and none of the exclusion criteria are fullfilled in the ANeED study:
- Male or female.
- Age ≥ 50 and ≤ 85 years of age.
- Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or Mild Cognitive Impairment in DLB (DLB-MCI).
- MMSE score>=15
- Able and willing to provide informed consent prior to any study related assessments and procedures at screening visit 1.
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- Capable of complying with all study procedures.
- Willing to provide blood samples for genetic analyses of APOE and GBA.
- 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)).
- Able to travel to the participating study site.
- 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.
Who cannot join
- Current treatment with anticoagulants (e.g. warfarin) that might preclude safe completion in the opinion of the Investigator.
- Current use of investigational medicinal product or participation in another interventional clinical trial or who have done so within 30 days prior to the first dose in the current study.
- Exposure to more than three investigational medicinal products within 12 months prior to the first dose in the current study;
- Confirmed dysphagia that would preclude self-administration of ambroxol up to 6 tablets daily for the duration of day 1 to day 550/Month 18.
- Significant known lower spinal malformations or other spinal abnormalities that would preclude lumbar puncture.
- History of known sensitivity to the study medication, ambroxol or its excipients (lactose monohydrate, granulated microcrystalline cellulose, copovidone and magnesium stearate) in the opinion of the investigator that contraindicates their participation.
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- History of known rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- History of illegal substance abuse, drug abuse or alcoholism in the opinion of the Investigator that would preclude participation in the study.
- Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of the study drug.
- Pregnant or breastfeeding; All participants of child bearing potential in the opinion of the Investigator that would preclude participation in the study and who do not agree to use double-barrier birth control or abstinence while participating in the study and for two weeks following the last dose of study drug;
- Any clinically significant or unstable psychiatric, medical or surgical condition that in the opinion of the PI or PI-delegated clinician may put the participant at risk when participating in the study or may influence the results of the study or affect the participant's ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ECG), or laboratory tests.
- Such conditions may include:
- Impaired renal function
- Moderate/Severe hepatic impairment
- A major cardiovascular event (e.g. myocardial infarction, acute coronary syndrome, decompensated congestive heart failure, pulmonary embolism, coronary revascularisation that occurred within 6 months prior to the screening visit.
- Major depression, delirium or psychosis not related to DLB.
- Metastatic cancer or terminal illness.
- Planned major surgery or other major treatments during study period that will interfere with study-obligations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Helse Fonna
Haugesund, Rogaland, 5528
Arvid Rongve, PhD, 90548749, arvid.rongve@helse-fonna.no
Dag Årsland, Professor
About this study
Official title: A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial to Demonstrate Clinical Efficacy on Cognitive, Neuropsychiatric and Functional Outcomes of Ambroxol in New and Early Patients With Prodromal and Mild Dementia With Lewybodies (ANeED) - Joint Effort 21: eHealth and a PPI-program in Dementia With Lewybodies (DLB)
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.
Read the 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.
- Conditions
- Dementia, Lewy Body
- Being tested
- Digital biomarkers
- Keywords
- dementia, lewy, wearable, sensor, digital, device, monitoring, actigraphy
- Medical subject headings
- Lewy Body Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital biomarkersDevice
Digital application Smartwatch Sleep monitor Movement sensor EEG-sensor
| Study group | Role | What they receive |
|---|---|---|
| Ambroxol: Digital biomarkers | Oral ambroxol medication, from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)) Receives: Device: Digital biomarkers | |
| Placebo: Digital biomarkers | Oral placebo medication, from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)). Receives: Device: Digital biomarkers | |
| Caregivers | Primary family caregivers to participants Receives: Device: Digital biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital biomarkers for diagnostic support and medication efficacy
Measured: All patient visits from start to 18 months (end of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, Lewy BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Fonna, Helse Stavanger HF, University Hospital, Akershus, Ullevaal University Hospital, Haraldsplass Deaconess Hospital, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Arvid Rongve, PhD, Principal investigator, University of Bergen / Helse Fonna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773443
- Sponsor's protocol ID
- 103362
- Acronym
- JointEffort21
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial to Demonstrate Clinical Efficacy on Cognitive, Neuropsychiatric and Functional Outcomes of Ambroxol in New and Early Patients With Prodromal and Mild Dementia With Lewybodies (ANeED) - Joint Effort 21: eHealth and a PPI-program in Dementia With Lewybodies (DLB)
- ClinicalTrials.gov ID
- NCT05773443
- Acronym / sponsor ID
- JointEffort21 / 103362
- Conditions
- Dementia, Lewy Body
- Keywords
- dementia, lewy, wearable, sensor, digital, device, monitoring, actigraphy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Helse Fonna, Helse Stavanger HF, University Hospital, Akershus, Ullevaal University Hospital, Haraldsplass Deaconess Hospital, St. Olavs Hospital
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ambroxol: Digital biomarkers | – | Device: Digital biomarkersOral ambroxol medication, from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)) |
| Placebo: Digital biomarkers | – | Device: Digital biomarkersOral placebo medication, from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)). |
| Caregivers | – | Device: Digital biomarkersPrimary family caregivers to participants |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants already included in ANeED drug trial with willingness to comply to the additional study.
Key inclusion criteria (13 listed)
- A patient is eligible when all inclusion criteria and none of the exclusion criteria are fullfilled in the ANeED study:
- Male or female.
- Age ≥ 50 and ≤ 85 years of age.
- Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or Mild Cognitive Impairment in DLB (DLB-MCI).
- MMSE score>=15
Key exclusion criteria (18 listed)
- Current treatment with anticoagulants (e.g. warfarin) that might preclude safe completion in the opinion of the Investigator.
- Current use of investigational medicinal product or participation in another interventional clinical trial or who have done so within 30 days prior to the first dose in the current study.
- Exposure to more than three investigational medicinal products within 12 months prior to the first dose in the current study;
- Confirmed dysphagia that would preclude self-administration of ambroxol up to 6 tablets daily for the duration of day 1 to day 550/Month 18.
- Significant known lower spinal malformations or other spinal abnormalities that would preclude lumbar puncture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital biomarkersDigital application Smartwatch Sleep monitor Movement sensor EEG-sensor | Device | Ambroxol: Digital biomarkers, Caregivers, Placebo: Digital biomarkers |
Primary outcome
Digital biomarkers for diagnostic support and medication efficacy
Time frame: All patient visits from start to 18 months (end of treatment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arvid Rongve, PhD principal investigator
University of Bergen / Helse Fonna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, Lewy Body, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arvid Rongve, PhD (90548749, arvid.rongve@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital biomarkers for diagnostic support and medication efficacy (time frame: All patient visits from start to 18 months (end of treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.