Dementia With Lewy BodiesPhase 2ANeEDNCT04588285
Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial
A Phase 2 study testing Ambroxol in people with Dementia With Lewy Bodies, run by Helse Fonna at 8 sites in Norway.
Trial summary
This is a confirmatory investigational medicinal product (IMP) study to investigate the effects on cognition, functional decline and on neuropsychiatric symptoms of the Glucocerebrosidase (GCase) enhancing chaperone ambroxol in participants diagnosed with prodromal and early dementia with Lewybodies (DLB). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- Ambroxol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 8 sitesNorway
- Study dates
- 4 May 2021to 15 Sep 2027
- Phase
- Phase 2
- 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
Who may be able to join
- 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.
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- 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.
- 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
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Norway8 sites, 8 recruiting
- Recruiting
Haraldsplass Deaconess Hospital
Bergen
Ragnhild Eide Skogseth, MD, +4799298171, ragnhild.skogseth@gmail.com
Ragnhild Eide Skogseth, MD
- Recruiting
University Hospital, Akershus
Hågån
Nikias Siafarikas, MD, +4796884452, Nikias.Siafarikas@ahus.no
Nikias Siafarikas, MD
- Recruiting
Helse Fonna
Haugesund, Haugesund, 5504
Arvid Rongve, Phd, 90548749, arvid.rongve@helse-fonna.no
Dag Årsland, Professor
- Recruiting
University Hospital, Akershus
Lørenskog
Tormod Fladby, Professor, +47 92817764, tormod.fladby@medisin.uio.no
Tormod Fladby, Professor
- Recruiting
Oslo University Hospital
Oslo
Anne-Brita Knapskog, Professor, +47 22 11 80 80, anne-brita@knapskog.net
Anne-Brita Knapskog, Professor
- Recruiting
Stavanger University Hospital
Stavanger
Dag Aarsland, Phd, +4797575804, daarsland@gmail.com
Dag Aarsland, Phd
- Recruiting
University Hospital North-Norway
Tromsø
Ole Kristian Grønli, MD, +4791713535, Ole.k.Gronli@unn.no
Ole Kristian Grønli, MD
- Recruiting
Trondheim University Hospital
Trondheim
John Christian Fløvig, MD, +4797734770, flovig@ntnu.no
John Christian Fløvig, MD
About this study
Official title: A 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
This is a confirmatory investigational medicinal product (IMP) study to investigate the effects on cognition, functional decline and on neuropsychiatric symptoms of the Glucocerebrosidase (GCase) enhancing chaperone ambroxol in participants diagnosed with prodromal and early dementia with Lewybodies (DLB).
Read the detailed description
Participants will be recruited through established network of Norwegian Memory Clinics. Patients will be randomised to ambroxol with proven effect on the lysosomal and glucocerebrosidase pathology in DLB or placebo. The randomization will be stratified based on APOE e4 and on the concentration of A-beta in CSF. The frequency of GBA genotypes in the active treatment and placebo groups will be calculated at study end. The blinded phase will last for 18 months and an open extension with ambroxol will be offered to all participants for one additional year. The primary outcomes will be cognition, global function, disease stage, progression, and neuropsychiatric symptoms. Secondary outcomes will be on sleep disturbances, falls, fluctuations and parkinsonism, and exploratory outcomes will be impact on the potential biomarkers for drug effects defined as qEEG, DaTSCAN, MRI and α-synuclein in CSF. One hundred and eighty participants will be recruited in total. Each participant will orally self-administer or administer by a caregiver ambroxol or placebo at 5 intra-participant dose escalations 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)).Participants will be subjected to clinical and laboratory assessments to assess the safety, tolerability effects of ambroxol on blood biomarkers and MRI, DaTSCAN, ECG, EEG and lumbar puncture. Each participant will undergo 8 hospital visits and 16 telephone visits for the blinded phase of the study during the first 18 months. Hospital visits will additionally include 1 or 2 screening appointments within 60 days of Day 1 hospital visit (at which participants will receive the first dose of ambroxol), followed by visits at week 4, week 8, week 24, week 36, week 52, month 15 and month 18. Participants will receive a telephone call 3 days after lumbar puncture to record any complaints. Participants will receive 16 telephone calls to record any drug related adverse events in between hospital visits, between 1-3 days before and after each dose escalation (day 1, 8, 15, 22 and 29, week 12,16, 20, 28, 32, 40, 44, 48 and month 13, 14, 16 and 17). All participants will be offered treatment with the IMP for 12 additional months from month 18 - month 30.
- Conditions
- Dementia With Lewy Bodies
- Being tested
- Ambroxol, Placebo
- Keywords
- Cognitive, Neuropsychiatric, Functional Outcomes, New and Early Patients, Prodromal, Mild Dementia, Lewybodies
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbroxolDrug
Also called Mucosolvan
Oral ambroxol medication (60 mg) 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)
PlaceboDrug
Oral placebo medication (60 mg) 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)
| Study group | Role | What they receive |
|---|---|---|
| Ambroxol | Experimental | 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: Drug: Ambroxol |
| Placebo | Experimental | 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: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the incidence, nature and severity of AE's and SAE's from baseline.
Change in the number of participants with AE's and SAE's.
Measured: All patient visits including phonecalls trough study completion, planned duration 18 months
Change in the number of participants with treatment discontinuations and study discontinuation due to AEs from baseline.
Change from baseline in the number of participants with treatment and/or study discontinuation will be used to demonstrate safety and tolerability
Measured: All patient visits including phonecalls trough study completion, planned duration 18 months
Change in the number of participants with electrocardiogram (ECG) abnormalities.
Including QTc interval.
Measured: Through study completion at the following visits: Screening, Baseline, week 4, week 24, week 36, week 52, month 15, and month 18.
Change in blood analyses from baseline over time abnormalities.
Change from baseline in number of participants with abnormal changes in clinical laboratory blood tests from baseline over time for safety.
Measured: Through study completion at the following visits: Screening, week 4, week 8, week 24, week 36, week 52, month 15, and month 18.
Change in MMSE-NR3 (Mini Mental Status Examination, Norwegian revised version) over time.
To confirm the effect of the IMP ambroxol in participants diagnosed with DLB measured by a defined battery of cognitive tests defining MMSE-NR3 as the primary outcome.
The MMSE-NR3 is a screening test for cognitive impairment that spans the visuospatial/executive, naming, memory, attention, language, delayed recall and orientation domains (score range from 0 to 30 points).
Measured: Through study completion at the following visits: Screening, week 24, week 36, week 52, Month 18.
ADCS-CGIC (Clinician's Global Impression of Change)
To confirm the effect of the IMP Ambroxol on the rate of functional decline in DLB.
Measured: Through study completion at the following visits: Screening, week 24, week 36, week 52, month 18.
Change in CDR-SB (Clinical Dementia Rating-Sum of Boxes).
Measure Rate of decline from screening to study completion at month 18 using CDR-SB.
Measured: Through study completion at the following visits: Screening, week 24, week 36 week 52, Month 18.
Change NPI (neuropsychiatric inventory)
To confirm the effect of the IMP Ambroxol on neuropsychiatric symptoms in DLB from screening to study completion at month 18 by using NPI.
The NPI is a semistructured clinician interview of caretakers in which the severity and frequency of disturbance in 12 symptom domains is rated. The scoring reflects not only the effect on the patient, but also the extent to which the symptom causes distress in the caregiver.
Score 0-144. The higher the score the more disease progression.
Measured: Through study completion at the following visits: Screening, week 24, week 36, week 52, month 18.
GDS (geriatric depression scale) - 15 items
To confirm the effect of the IMP Ambroxol on neuropsychiatric symptoms in DLB from screening to study completion at month 18 by using GDS.
The Geriatric Depression Scale (GDS) is a 15-item self-report assessment used to identify depression in the elderly. A high score usually always indicates depression and more severe depression.
Measured: Through study completion at the following visits: Screening, week 24, week 36, week 52, month 18.
Secondary outcomes (4)
Mayo Sleep Questionnaire (MSQ).
To confirm the effect of The IMP Ambroxol in DLB measured on MSQ for evaluating sleep disturbances.
MSQ is developed and validated in English version to detect Rapid Eye Movement - (REM) Sleep Behavior Disorder - (RBD) and several other sleep disorders in people with dementia and Parkinson's disease. RBD is part of the diagnosis of dementia with Lewy bodies.
No score - only yes/no questions.
Measured: Through study completion at the following visits: Screening, week 24, week 36, week 52, Month 18.
Mayo Fluctuation Scale (MFS)
To confirm the effect of The IMP Ambroxol in DLB measured on MFS for evaluating fluctuations.
The Mayo Fluctuations Scale is a short questionnaire that evaluates cognitive fluctuation.
Three or four points shows cognitive fluctuation. Scale 0-4.The higher the score the more disease progression
Measured: Through study completion at the following visits: Screening, week 24, week 36, week 52, Month 18.
Unified Parkinson Disease Rating Scale (UPDRS-III)
To confirm the effect of The IMP Ambroxol in DLB measured on UPDRS-III for evaluating Parkinsonism.
The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease. The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease. Following the UPDRS scores over time provides insight into the patient's disease progression.
Scale 0-138 points. The higher the score the more disease progression
Measured: Through study completion at the following visits: Screening, week 8, week 24, week 36, week 52, Month 18.
Number of falls and related injury
To confirm the effect of The IMP Ambroxol in DLB measured on questions evaluating number of falls and related injury.
Measured: Through study completion at the following visits: Screening, week 24, week 36, week 52, Month 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start4 May 2021
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy BodiesStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will receive 5 intra-participant dose escalations 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) with ambroxol or placebo for the duration of 18 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Fonna
- Sponsor type
- University, hospital or other
- Collaborators
- Klinbeforsk, Helse-Bergen HF, Helse Stavanger HF, Oslo University Hospital, University Hospital, Akershus, Haraldsplass Deaconess Hospital, St. Olavs Hospital, University Hospital of North Norway
- Responsible party
- Sponsor
- Investigators
- Arvid Rongve, Phd, Principal investigator, arvid.rongve@helse-fonna.no
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588285
- Sponsor's protocol ID
- 3.4 Date: 11th of March 2024
- Acronym
- ANeED
- Status last verified
- Apr 2026
- First submitted
- 26 Aug 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT04588285
- Acronym / sponsor ID
- ANeED / 3.4 Date: 11th of March 2024
- Conditions
- Dementia With Lewy Bodies
- Keywords
- Cognitive, Neuropsychiatric, Functional Outcomes, New and Early Patients, Prodromal, Mild Dementia, Lewybodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Helse FonnaUniversity, hospital or other
- Collaborators
- Klinbeforsk, Helse-Bergen HF, Helse Stavanger HF, Oslo University Hospital, University Hospital, Akershus, Haraldsplass Deaconess Hospital, St. Olavs Hospital, University Hospital of North Norway
- Study start
- 4 May 2021 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 19 Oct 2020 (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.
This is a confirmatory investigational medicinal product (IMP) study to investigate the effects on cognition, functional decline and on neuropsychiatric symptoms of the Glucocerebrosidase (GCase) enhancing chaperone ambroxol in participants diagnosed with prodromal and early dementia with Lewybodies (DLB).
Detailed description
Participants will be recruited through established network of Norwegian Memory Clinics. Patients will be randomised to ambroxol with proven effect on the lysosomal and glucocerebrosidase pathology in DLB or placebo. The randomization will be stratified based on APOE e4 and on the concentration of A-beta in CSF. The frequency of GBA genotypes in the active treatment and placebo groups will be calculated at study end. The blinded phase will last for 18 months and an open extension with ambroxol will be offered to all participants for one additional year. The primary outcomes will be cognition, global function, disease stage, progression, and neuropsychiatric symptoms. Secondary outcomes will be on sleep disturbances, falls, fluctuations and parkinsonism, and exploratory outcomes will be impact on the potential biomarkers for drug effects defined as qEEG, DaTSCAN, MRI and α-synuclein in CSF. One hundred and eighty participants will be recruited in total. Each participant will orally self-administer or administer by a caregiver ambroxol or placebo at 5 intra-participant dose escalations 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)).Participants will be subjected to clinical and laboratory assessments to assess the safety, tolerability effects of ambroxol on blood biomarkers and MRI, DaTSCAN, ECG, EEG and lumbar puncture. Each participant will undergo 8 hospital visits and 16 telephone visits for the blinded phase of the study during the first 18 months. Hospital visits will additionally include 1 or 2 screening appointments within 60 days of Day 1 hospital visit (at which participants will receive the first dose of ambroxol), followed by visits at week 4, week 8, week 24, week 36, week 52, month 15 and month 18. Participants will receive a telephone call 3 days after lumbar puncture to record any complaints. Participants will receive 16 telephone calls to record any drug related adverse events in between hospital visits, between 1-3 days before and after each dose escalation (day 1, 8, 15, 22 and 29, week 12,16, 20, 28, 32, 40, 44, 48 and month 13, 14, 16 and 17). All participants will be offered treatment with the IMP for 12 additional months from month 18 - month 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will receive 5 intra-participant dose escalations 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) with ambroxol or placebo for the duration of 18 months.
| Arm | Type | Receives |
|---|---|---|
| Ambroxol | Experimental | Drug: AmbroxolOral 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 | Experimental | Drug: PlaceboOral 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)). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| AmbroxolAlso: MucosolvanOral ambroxol medication (60 mg) 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) | Drug | Ambroxol |
| PlaceboOral placebo medication (60 mg) 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) | Drug | Placebo |
Primary outcome
Change in the incidence, nature and severity of AE's and SAE's from baseline.
Time frame: All patient visits including phonecalls trough study completion, planned duration 18 months
Change in the number of participants with AE's and SAE's.
Change in the number of participants with treatment discontinuations and study discontinuation due to AEs from baseline.
Time frame: All patient visits including phonecalls trough study completion, planned duration 18 months
Change from baseline in the number of participants with treatment and/or study discontinuation will be used to demonstrate safety and tolerability
Change in the number of participants with electrocardiogram (ECG) abnormalities.
Time frame: Through study completion at the following visits: Screening, Baseline, week 4, week 24, week 36, week 52, month 15, and month 18.
Including QTc interval.
Change in blood analyses from baseline over time abnormalities.
Time frame: Through study completion at the following visits: Screening, week 4, week 8, week 24, week 36, week 52, month 15, and month 18.
Change from baseline in number of participants with abnormal changes in clinical laboratory blood tests from baseline over time for safety.
Change in MMSE-NR3 (Mini Mental Status Examination, Norwegian revised version) over time.
Time frame: Through study completion at the following visits: Screening, week 24, week 36, week 52, Month 18.
To confirm the effect of the IMP ambroxol in participants diagnosed with DLB measured by a defined battery of cognitive tests defining MMSE-NR3 as the primary outcome. The MMSE-NR3 is a screening test for cognitive impairment that spans the visuospatial/executive, naming, memory, attention, language, delayed recall and orientation domains (score range from 0 to 30 points).
ADCS-CGIC (Clinician's Global Impression of Change)
Time frame: Through study completion at the following visits: Screening, week 24, week 36, week 52, month 18.
To confirm the effect of the IMP Ambroxol on the rate of functional decline in DLB.
Change in CDR-SB (Clinical Dementia Rating-Sum of Boxes).
Time frame: Through study completion at the following visits: Screening, week 24, week 36 week 52, Month 18.
Measure Rate of decline from screening to study completion at month 18 using CDR-SB.
Change NPI (neuropsychiatric inventory)
Time frame: Through study completion at the following visits: Screening, week 24, week 36, week 52, month 18.
To confirm the effect of the IMP Ambroxol on neuropsychiatric symptoms in DLB from screening to study completion at month 18 by using NPI. The NPI is a semistructured clinician interview of caretakers in which the severity and frequency of disturbance in 12 symptom domains is rated. The scoring reflects not only the effect on the patient, but also the extent to which the symptom causes distress in the caregiver. Score 0-144. The higher the score the more disease progression.
GDS (geriatric depression scale) - 15 items
Time frame: Through study completion at the following visits: Screening, week 24, week 36, week 52, month 18.
To confirm the effect of the IMP Ambroxol on neuropsychiatric symptoms in DLB from screening to study completion at month 18 by using GDS. The Geriatric Depression Scale (GDS) is a 15-item self-report assessment used to identify depression in the elderly. A high score usually always indicates depression and more severe depression.
4 secondary outcomes
Mayo Sleep Questionnaire (MSQ).
Time frame: Through study completion at the following visits: Screening, week 24, week 36, week 52, Month 18.
Mayo Fluctuation Scale (MFS)
Time frame: Through study completion at the following visits: Screening, week 24, week 36, week 52, Month 18.
Unified Parkinson Disease Rating Scale (UPDRS-III)
Time frame: Through study completion at the following visits: Screening, week 8, week 24, week 36, week 52, Month 18.
Number of falls and related injury
Time frame: Through study completion at the following visits: Screening, week 24, week 36, week 52, Month 18.
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 5 May 2026.
- Rongve, A., et al. Demens med Lewylegemer- utredning og behandling. 2017Link provided by the sponsor.
- Aarsland, D. MULTI-CENTRE COHORT-STUDIES IN LEWY-BODY DEMENTIA. 2015Link provided by the sponsor.
- Individual participant dataSharing planned: No. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
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Lewy Body Dementia Psychosis
RecruitingPhase 3
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
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
arvid.rongve@helse-fonna.no
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ambroxol in people with Dementia With Lewy Bodies, run by Helse Fonna at 8 sites 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 15 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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@helse-fonna.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the incidence, nature and severity of AE's and SAE's from baseline. (time frame: All patient visits including phonecalls trough study completion, planned duration 18 months). The study lists 9 primary outcomes in all. 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 5 May 2026.