ANeED Joint Effort 21: eHealth and a PPI Program in Dementia With Lewybodies (DLB)

NCT05773443 | Recruiting

• 1 other identifier: 103362
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia, Lewy Body

Keywords

dementia, lewy, wearable, sensor, digital, device, monitoring, actigraphy

Outcome Measures

Primary Outcomes (1)

• Digital biomarkers for diagnostic support and medication efficacy

  All patient visits from start to 18 months (end of treatment).

Study Arms (3)

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))

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)).

Device: Digital biomarkers

Caregivers

Primary family caregivers to participants

Device: Digital biomarkers

Interventions

Digital biomarkers DEVICE

Digital application Smartwatch Sleep monitor Movement sensor EEG-sensor

Ambroxol: Digital biomarkers; Caregivers; Placebo: Digital biomarkers

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants already included in ANeED drug trial with willingness to comply to the additional study.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• University of Bergen: lead
• Helse Fonna: collaborator
• Helse Stavanger HF: collaborator
• University Hospital, Akershus: collaborator
• Ullevaal University Hospital: collaborator
• Haraldsplass Deaconess Hospital: collaborator
• St. Olavs Hospital: collaborator

Study Sites (1)

Helse Fonna

Haugesund, Rogaland, 5528, Norway

RECRUITING

MeSH Terms

Conditions

Lewy Body Disease; Dementia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Arvid Rongve, PhD

  University of Bergen / Helse Fonna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arvid Rongve, PhD

CONTACT

90548749; arvid.rongve@uib.no

Jessica Hubbers, MSc

CONTACT

91692898; jessica.hubbers@helse-fonna.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

NO (1)