Optimisation of Antipsychotic Drug Use in Older People

Study Overview
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Brief Summary
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Drugs such as amisulpride, known as antipsychotic drugs, are used to treat troublesome and distressing symptoms in older people. Although these drugs can be beneficial, they are associated with side effects, particularly in patients with dementia and schizophrenia- like illness. There is an urgent clinical need to understand why this is the case, to guide treatment strategies. This study aims to utilise brain imaging techniques that measure the action of antipsychotic drugs in the brain to explore the causes of this susceptibility in older people with dementia and schizophrenia-like illness, and translate these findings into direct patient benefit. The aim of the study is to investigate and compare the relationship between the action of amisulpride at brain sites during the first 10 weeks of amisulpride treatment in two patient groups - Alzheimer's disease and schizophrenia-like illness. Imaging data will be combined with data on drug dosage, levels of drug in the bloodstream and clinical response (symptom reduction and motor side effects) during dose titration.Dose-response modelling will be carried out in both groups to establish the minimum clinically effective dose of amisulpride, optimum dose range and impact of variability and covariates on exposure-response relationships

Official Title
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Rationalisation of Antipsychotic Drug Use in Older People, Using [18F]-Fallypride PET

Conditions
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Alzheimer's Disease, Schizophrenia

Intervention / Treatment
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* Drug: Patients- dose titration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Treatment and Control (antipsychotic free) Group Schizophrenia meet diagnostic criteria for schizophrenia-like illness aged between 60 and 95 years of age score <6 on the Geriatric depression scale Alzheimer's meet diagnostic criteria for AD score <=4 on the Modified Hachinski Ischaemia Scale score < 8 on a modified version of the UPDRS aged between 60 and 95 years of age score <6 on the Geriatric depression scale Exclusion Criteria Treatment Group Schizophrenia current or past history of addiction, traumatic brain injury or epilepsy prescribed any drug that interferes with brain dopamine in past 2 weeks (6 weeks if depot antipsychotic medication). medical conditions that might affect Ability to tolerate a brain scan unable to give informed consent Alzheimer's current or past history of psychiatric illness, traumatic brain injury or epilepsy prescribed an antipsychotic or other oral drug that interferes with brain dopamine function within the past 2 weeks (6 weeks if depot antipsychotic medication). medical conditions that might affect a person's ability to tolerate a brain scan Control (antipsychotic free) Group Schizophrenia Prescribed psychotropic medication unable to give informed consent Alzheimer's • Prescribed psychotropic medication

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients - dose titration<br>Amisulpride 50-200mg, 4-12 weeks, with brain imaging | Drug: Patients- dose titration<br>* dose titration (patients) - 4-10 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose titration | receptor occupancy compared across 2 patient groups following dose-titration | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amisulpride, receptor occupancy, antipsychotic sensitivity