COBALT
Overview
COmBining memantine And cholinesterase inhibitors in Lewy body dementia Treatment trial
Are you interested in taking part in a medical research trial?
The trial will look at the use of a drug called Memantine for treatment of people with Dementia with Lewy Bodies (DLB) and Parkinson’s Disease Dementia (PDD) symptoms. The aim of the COBALT trial is to find out if Memantine treatment can help improve overall health and functioning for people with DLB or PDD.
What does taking part involve?
o If you agree to take part, you will join one of two treatment groups for 12 months:
- a placebo (‘dummy’ drug) group
OR
- a medication (Memantine) group
o You will have planned visits and phone calls with the local trial team, who will ask you about your symptoms, how you feel and your trial treatment.
o A family member or person who knows you well will also be asked to answer questions about your symptoms and about how they are feeling.
Are you interested in taking part in this study?
Planned end date
01 Apr 2025 20:54Conditions
DementiaInclusion Criteria
• Patients with a diagnosis or clinical features consistent with established consensus criteria for probable DLB or probable PDD
• aged ≥ 50 years (no upper limit)
• MMSE score ≥ 8*
Exclusion Criteria
• Atypical clinical features or course that might suggest an alternative dementia diagnosis.
• Any clinically relevant concomitant disease that will affect ability to participate in the trial including,but not limited to,chronic renal disease stage 5,history of acute or chronic pancreatitis,epilepsy or former history of convulsions,patients with recent myocardial infarction (within last 6 months), uncompensated congestive heart failure (NYHA III-IV),or uncontrolled hypertension.
• Patients with severe hepatic impairment based on known history and/or significant abnormalities identified in blood liver function tests (e.g. levels in LFTs that are 2 to 3 times higher than the upper limit of normal),which in the judgement of the local PI would exclude the patient from the trial.
• Patients taking memantine,amantadine, ketamine or dextromethorphan.
• Any neurological or major psychiatric diagnosis that may be contributing to cognitive impairment above and beyond that caused by the patient's DLB/PDD.
• Renally impaired patients with eGFR <35 mL/min/1.73m2
• Patients without a reliable caregiver/informant.