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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
John-Paul
Taylor
+44 191 2081311
john-paul.taylor@newcastle.ac.uk
Ms
Sarah
Dunn
+44 191 208 2521
cobalt.study@ncl.ac.uk
Ms
Lesley
Vidaurre
-
Vidaurre.l@wehi.edu.au
Prof
Rosie
Watson
-
watson.r@wehi.edu.au
More information about this study, what is involved and how to take part can be found on the study website.
Dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD) are related complex illnesses with a wide range of distressing symptoms. People with DLB/PDD have worse quality of life, more complex symptoms, higher care costs, and are more sensitive to medications than people with Alzheimer’s disease (AD).
Acetylcholinesterase Inhibitors (AChEI) are commonly used medicines that can help people with DLB/PDD by improving day to day functioning and thinking abilities. Another drug which might help is memantine, used to treat moderate to severe confusion in AD. It may help to improve memory, awareness and the ability to perform daily functions; however, it is not clear if adding memantine to AChEI is beneficial for people with DLB/PDD.
The aim of this trial is to find out if adding memantine to AChEI improves overall health and functioning for people with DLB or PDD.
COBALT is a double-blind, placebo-controlled, randomised trial to assess the clinical and cost-effectiveness of memantine compared to placebo in patients on an AChEI with DLB (COBALT-DLB) and PDD (COBALT-PDD). There are two separate COBALT trials being carried out using the same protocol, one in the UK and one in Australia. We plan to recruit a total of 372 patients and their caregivers/informants. The UK trial will recruit 300 participants from 30 sites and the Australian trial will recruit 72 participants from up to 5 sites. UK and Australian data will be combined for analysis.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 21/12/2023:
1. Patients with a diagnosis or clinical features consistent with established consensus criteria for probable DLB or probable PDD
2. Aged ≥55 years
3. MMSE score ≥8. Evidence of mild, moderate, or moderate to severe cognitive impairment on similar global cognitive scales previously completed by their clinical care team (e.g., Addenbrooke’s Cognitive Examination, Mini-Addenbrooke’s Cognitive Examination, Montreal Cognitive Assessment) can be used to pre-screen the patient, prior to approach.
4. Receiving a stable dose of AChEI for ≥12 weeks prior to baseline, with no expected plans for dose adjustment during the trial period; dose adjustment will be allowed during the trial, if clinically indicated, following discussion with PI and, if required, the central trial team
5. If receiving any antiparkinsonian treatment, antidepressants, anxiolytics, antipsychotics, or other drugs with significant psychotropic effects then dose must be stable for a minimum of 4 weeks prior to enrolment with no expected plans for dose adjustment during the trial period. Dose adjustment will be allowed during the trial if clinically indicated and will be documented. If a change in medication with psychotropic effects is required, this decision can be made by the treating clinician (e.g., starting an antidepressant in clinic) without consultation with the CI. In some instances, the clinician may feel it is appropriate/relevant to discuss this with the PI prior to prescribing, for example, if the clinician feels that the medication change may have an impact on the trial and/or trial medication. Any changes should however be documented in the patient’s concomitant medications electronic Case Report Form (eCRF).
6. Patients who lack capacity will be required to have a personal/professional nominated representative who is able to give informed consent on the patient’s behalf
7. Females must be postmenopausal and not receiving IVF treatment or must have undergone permanent sterilisation. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
8. Patients with sufficient knowledge of the English language or support to understand the Patient Information Sheet and complete the tr
You may not be able to take part if:
1. Atypical clinical features or course suggestive of an alternative dementia diagnosis.2. 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.3. Patients with severe hepatic impairment based on known history and/or significant abnormalities identified in blood liver function tests (for example, levels in liver function tests that are 2-3 times higher than the upper limit of normal), which in the judgement of the local PI would exclude the patient from the trial.*4. Patients taking memantine, amantadine, ketamine, or dextromethorphan.5. Any neurological or major psychiatric diagnosis that may be contributing to cognitive impairment above and beyond that caused by the patients DLB or PDD. 6. Renally impaired patients with eGFR <35 mL/min/1.73m².†7. Currently taking part in another clinical trial that would interfere with the outcomes of the COBALT trial. 8. If in the opinion of the investigator, the patient would be unable to comply with the trial procedures or has difficulty taking oral medications.9. Patients without a reliable caregiver/informant.*LFTs should be repeated if they were not carried out at screening and were abnormal in the last 6 months and/or, in the judgement of the local PI, are clinically relevant to check before deciding trial entry. †U&Es should be repeated if they were not carried out at screening and were abnormal in the last 6 months and/or, in the judgement of the local PI, are clinically relevant to check before deciding trial entry. For example, a borderline eGRF <45 mL/min/1.73m².
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Sarah
Dunn
+44 191 208 2521
cobalt.study@ncl.ac.uk
Prof
John-Paul
Taylor
+44 191 2081311
john-paul.taylor@newcastle.ac.uk
Prof
Rosie
Watson
-
watson.r@wehi.edu.au
Ms
Lesley
Vidaurre
-
Vidaurre.l@wehi.edu.au
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Cumbria Northumberland Tyne and Wear NHS Foundation Trust; University of Melbourne and funded by Health Technology Assessment Programme; National Health and Medical Research Council.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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