COBALT

COmBining memantine And cholinesterase inhibitors in Lewy body dementia treatment Trial

Study stage: Set-up
Sponsor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Funder: NIHR HTA
Therapeutic area: Neurological
Type of study: CTIMP

Aim:

1) To determine the effectiveness of augmenting AChEI with memantine in patients with DLB.

2) To determine the effectiveness of augmenting AChEI with memantine in patients with PDD.

Primary Outcome:

For each trial, intention to treat analysis will evaluate the effect of AChEI plus memantine versus AChEI alone on ADCS-CGIC score at 26 weeks, adjusting for baseline disease severity (defined by level of cognitive impairment) and country.

Population: Adult
Phase: III
Design: Basket
Setting: Secondary care
Planned Sample Size: 372