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 (The ANeED study)

Conditions

Dementia with Lewy Bodies

Brief summary

Mean score on the MMSE at screening to 18 months in the intervention group compared to the control group.

Detailed description

Mean score in MMSE at 18 months in the ambroxol group compared to the placebo group in subgroups defined by APOE and GBA genotypes and A-Beta in CSF., Mean score at 18 months between the ambroxol group compared to the placebo group for the clock drawing test, COWAT immediate and delayed recall, Trail making test A&B, VOSP siluettes and FAS test., Mean score in the Clinician’s Global Impression of Change (ADCS-CGIC) score at Month 18 in the ambroxol and placebo groups., Mean score in the total NPI score at Month 18 in the ambroxol group compared to the placebo group., Mean score on the UPDRS-part III motor part and the MAYO fluctuation scores at month 18, The number of participants with RBD defined from the Mayo Sleep Questionnaire at month 18 in ambroxol and placebo groups., The number of falls at month 18 in the ambroxol and in the placebo groups.

Related papers

No related papers found yet.

Interventions

DRUGPlacebo matching active treatment.

DRUGAmbroxol

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean score on the MMSE at screening to 18 months in the intervention group compared to the control group.	—

Secondary

Measure	Time frame
Mean score in MMSE at 18 months in the ambroxol group compared to the placebo group in subgroups defined by APOE and GBA genotypes and A-Beta in CSF., Mean score at 18 months between the ambroxol group compared to the placebo group for the clock drawing test, COWAT immediate and delayed recall, Trail making test A&B, VOSP siluettes and FAS test., Mean score in the Clinician’s Global Impression of Change (ADCS-CGIC) score at Month 18 in the ambroxol and placebo groups., Mean score in the total NPI score at Month 18 in the ambroxol group compared to the placebo group., Mean score on the UPDRS-part III motor part and the MAYO fluctuation scores at month 18, The number of participants with RBD defined from the Mayo Sleep Questionnaire at month 18 in ambroxol and placebo groups., The number of falls at month 18 in the ambroxol and in the placebo groups.	—

Measure

Time frame

Mean score in MMSE at 18 months in the ambroxol group compared to the placebo group in subgroups defined by APOE and GBA genotypes and A-Beta in CSF., Mean score at 18 months between the ambroxol group compared to the placebo group for the clock drawing test, COWAT immediate and delayed recall, Trail making test A&B, VOSP siluettes and FAS test., Mean score in the Clinician’s Global Impression of Change (ADCS-CGIC) score at Month 18 in the ambroxol and placebo groups., Mean score in the total NPI score at Month 18 in the ambroxol group compared to the placebo group., Mean score on the UPDRS-part III motor part and the MAYO fluctuation scores at month 18, The number of participants with RBD defined from the Mayo Sleep Questionnaire at month 18 in ambroxol and placebo groups., The number of falls at month 18 in the ambroxol and in the placebo groups.

—

Countries

Norway

Outcome results

None listed