Principal Investigator: Dr Sarah Wilson

Study summary:

COBALT is a randomised, double-blind, placebo-controlled clinical trial. It aims to find out if adding Memantine to a cholinesterase inhibitor (either donepezil, rivastigmine and galantamine) improves overall health and functioning for people with Dementia with Lewy Bodies (DLB) or Parkinson’s Disease Dementia (PDD).

The trial is sponsored by Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust and funded by the Health Technology Assessment | NIHR. The trial is managed by Newcastle Clinical Trials Unit.

A similar study will also be taking place in Australia and at the end of both studies the findings will be shared to help understand whether Memantine treatment when added to a cholinesterase inhibitor help people with DLB or PDD is helpful.

How will the trial be carried out?

Participants will attend at least three in person appointments; an initial appointment, with follow up appointments at 6 and 12 months. 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.

The study drug will be delivered in person by one of the research delivery team at Baseline, and weeks 14, 26 and 38. Participants will be given a diary to record when they take their study treatment and any adverse events, changes in other medications or visits to the doctors will be recorded.

There will be four additional appointments and an optional follow up call. These appointments will be to review medication and information recorded in the participants study diary.

Inclusion criteria:

• Patients with a diagnosis of probable DLB or probable PDD.
• Aged =55.
• Taking a cholinesterase inhibitor for at least 12 weeks
• Sufficient knowledge of the English language or support to understand the Patient Information Sheet and complete the trial assessments.

Exclusion criteria:

• Chronic renal disease stage 5
• History of acute or chronic pancreatitis
• Epilepsy or former history of convulsions
• History of Heart attack withing the last 6 months
• Untreated Hypertension
• Severe liver impairment
• Kidney Impairment Patients taking Memantine, amantadine, ketamine, or dextromethorphan
• Patients without a Study partner who is willing to also take part and answer questions.

Approvals:

The study was approved by Nottinghamshire Healthcare NHS Foundation Trust in September 2022.

Recruitment will continue until 31 May 2026.

Contact:

For information contact Senior Research Delivery Officer - Sue Smith Email: This email address is being protected from spambots. You need JavaScript enabled to view it. Tel: 0115 671 4623