Medication studies range from those targeting specific disorders and illnesses, to exploring general side-effects and understanding the various biometrics.
Current related studies open for recruitment
Summary
To find out if adding Memantine to Acetylcholinesterase Inhibitors (AChEI) improves overall health and functioning for people with DLB or PDD with two international, double-blind, placebo-controlled, randomised trials to assess the clinical and cost effectiveness. DLB/PDD patients aged 50+ with a MMSE score of ≥8 on a stable AChEI dose will be randomised to 1:1 Memantine or placebo for 52 weeks – both identical in procedure, with the only variant being the disease group. Participants and caregivers/ informants complete assessments at baseline, 26 weeks (primary, secondary and exploratory outcomes) and 52 weeks (secondary and exploratory outcomes). During these visits, assessments will be completed by the patient and their caregiver/ informant.
Inclusion criteria
1. Patients with a diagnosis or clinical consistent with established consensus criteria for probable DLB or probable PDD.
2. Aged 50+ (no upper limit)
3. Mini Mental State Examination (MMSE) score ≥8 (evidence of mild, moderate or moderate to severe (e.g., scoring 8-12/30) cognitive impairment or similar global cognitive scales (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 anti-parkinsonian treatment, anti-depressants, anxiolytics, anti-psychotics, 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 and to the end of the trial; doe 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 decisions can be made by the treating physician (e.g., starting an anti-depressant in clinic) without consultation with the CI. The clinician should attempt to discuss this with the PI prior to prescribing unless it is an emergency, and the change must be documented in the patient’s concomitant medications electronic Case Report Form (eCRF)).
6. Patients that lack capacity to consent will be included in the trial to ensure that the sample is representative of the population that is likely to benefit. Patients that lack capacity will be required to have a person/ professional legal representative who is able to give informed consent on the patient’s behalf.
7. Female patients who are yet to reach menopause must agree not to fall pregnant while taking IMP.
8. Patients with sufficient knowledge of the English language or support to understand the Participant Information Sheet and complete the trial assessments.
Exclusion criteria
1. Severe physical or life-threatening conditions which may limit ability for the subject to participant in the study. This includes cancer or other conditions with suspected survival time less than three years.
2. Other intracranial pathology (stroke, space occupying lesion, previous intracranial surgery).
3. Other physical or psychiatric conditions which may contribute to cognitive impairment.
4. Diagnosis of possible DLB with negative dopamine transporter scan (DaT scan).
5. More than five years use of antipsychotic drugs prior diagnosis.
6. Contraindications to Lumbar Puncture, inc. warfarin and anticoagulant use (except aspirin at doses of up to 100 mg or lower – if patient has consented to lumbar puncture).
7. Study partner who is unable to attend all study visits with the participant.
Targeted, end date and PI
EPUT: 36
31.08.25
PI: Dr Zuzana Walker
Study Lead: Lara Horrax
Summary
To investigate if genetic profiling can help optimise the prescribing of psychotropic medications, and lead to improved clinical outcomes and reduced side effects. Participants who consent to take part in the study will be offered genome-wide genotyping. To recruit adult patients with schizophrenia, delusional, schizophrenic or bipolar disorders. Hospital ward- or community centre-based initial assessment if the participant is an outpatient. Follow-up assessments can occur on the ward or in the community if the patient has been discharged. Final follow-up is based on clinical record.
Inclusion criteria
1. Patients aged 18+.
2. Men or women.
3. With an ICD10 diagnosis of any “mental, behavioural or neurodevelopmental disorders”, Codes F01 – F99.
Exclusion criteria
1. Patients with current high risks of self-harm or harm to others.
2. Patients who lack capacity to consent to taking part in the research.
Targeted, end date and PI
EPUT: 45
13.04.25
PI: Dr Shaimaa Aboelenien
Study Lead: Natalie Rodney