- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05773443
ANeED Joint Effort 21: eHealth and a PPI Program in Dementia With Lewybodies (DLB) (JointEffort21)
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Arvid Rongve, PhD
- Phone Number: 90548749
- Email: arvid.rongve@uib.no
Study Contact Backup
- Name: Jessica Hubbers, MSc
- Phone Number: 91692898
- Email: jessica.hubbers@helse-fonna.no
Study Locations
-
-
Rogaland
-
Haugesund, Rogaland, Norway, 5528
- Recruiting
- Helse Fonna
-
Contact:
- Arvid Rongve, Phd
- Phone Number: 90548749
- Email: arvid.rongve@helse-fonna.no
-
Principal Investigator:
- Dag Årsland, Professor
-
Principal Investigator:
- Tormod Fladby, Professor
-
Principal Investigator:
- Anne-Brita Knapskog, Professor
-
Principal Investigator:
- Ragnhild Skogseth, Consultant
-
Principal Investigator:
- John Fløvig, Associate professor
-
Principal Investigator:
- Ole Kristian Grønli, Consultant
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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))
|
Digital application Smartwatch Sleep monitor Movement sensor EEG-sensor
|
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)).
|
Digital application Smartwatch Sleep monitor Movement sensor EEG-sensor
|
Caregivers
Primary family caregivers to participants
|
Digital application Smartwatch Sleep monitor Movement sensor EEG-sensor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Digital biomarkers for diagnostic support and medication efficacy
Time Frame: All patient visits from start to 18 months (end of treatment).
|
All patient visits from start to 18 months (end of treatment).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arvid Rongve, PhD, University of Bergen / Helse Fonna
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 103362
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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