COBALT is a type of trial known as a ‘randomised controlled trial’.

‘Controlled’ means that we have a group of participants that will receive the active treatment (Memantine) and that the other group will receive a placebo (dummy drug). A controlled trial allows us to be able to compare the two groups to see if the active drug is more beneficial than the placebo.

‘Randomised’ means that the group a participant is put into, and whether they will receive Memantine or placebo (dummy drug), will be determined by chance, through a process called ‘randomisation’.

Randomisation helps us to have two groups of participants that are similar apart from the trial medication that they receive. The randomisation is carried out using a computer programme and cannot be chosen by the participant or their trial doctor.

Group 1: Placebo

Participants in group 1 will be given the placebo trial medication. This is a ‘dummy’ drug. It looks exactly the same as the real drug but it is made with non-active ingredients.

Group 2: Memantine

Participants in group 2 willbe given the active trial medication, Memantine. Only participants in this group will receive Memantine.

COBALT will take place in up to 25 NHS Trusts in the UK and a similar study will happen in up to 5 centres in Australia.

We plan to recruit 150 DLB patients and 150 PDD patients in the UK and 36 DLB patients and 36 PDD patients in Australia.

Recruitment will take place over 20 months from August 2022, closing in March 2024.

Participants will attend at least three in person appointments; an initial appointment, with follow up appointments 6 and 12 months after this. During these appointments, participants will also be asked to complete questionnaires about symptoms, quality of life and financial impact. Their trial partner, who will be someone who knows them well, will also complete questionnaires about the participant and about how they think they  are feeling. There will be four additional telephone appointments and an optional follow up call. The participants and their trial partner will be able to contact the local trial team outside of their scheduled visits, should they have any questions.

More detail on the trial process can be found here