Alzheimer's DiseasePhase 4NCT01454453
Optimisation of Antipsychotic Drug Use in Older People
A Phase 4 study testing Patients- dose titration in people with Alzheimer's Disease and Schizophrenia, run by Institute of Psychiatry, London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Alzheimer's Disease, Schizophrenia
- What is being tested?
- Patients- dose titration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Psychiatry, Kings College London
London, SE58AF
About this study
Official title: Rationalisation of Antipsychotic Drug Use in Older People, Using [18F]-Fallypride PET
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
- Conditions
- Alzheimer's Disease, Schizophrenia
- Being tested
- Patients- dose titration
- Keywords
- amisulpride, receptor occupancy, antipsychotic sensitivity
- Medical subject headings
- Alzheimer Disease, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients- dose titrationDrug
dose titration (patients) - 4-10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients - dose titration | Experimental | Amisulpride 50-200mg, 4-12 weeks, with brain imaging Receives: Drug: Patients- dose titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose titration
receptor occupancy compared across 2 patient groups following dose-titration
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startMay 2012
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Failure to recruit people with very late onset schizophrenia like psychosis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Reeves, Institute of Psychiatry, London
- Investigators
- Suzanne J Reeves, MBChB, PhD, Principal investigator, Institute of Psychiatry, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454453
- Sponsor's protocol ID
- 2167SR
- Status last verified
- Apr 2017
- First submitted
- 12 Oct 2011
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationalisation of Antipsychotic Drug Use in Older People, Using [18F]-Fallypride PET
- ClinicalTrials.gov ID
- NCT01454453
- Acronym / sponsor ID
- 2167SR
- Conditions
- Alzheimer's Disease, Schizophrenia
- Keywords
- amisulpride, receptor occupancy, antipsychotic sensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit people with very late onset schizophrenia like psychosis
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Institute of Psychiatry, LondonUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients - dose titration | Experimental | Drug: Patients- dose titrationAmisulpride 50-200mg, 4-12 weeks, with brain imaging |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients- dose titrationdose titration (patients) - 4-10 weeks | Drug | Patients - dose titration |
Primary outcome
dose titration
Time frame: 12 weeks
receptor occupancy compared across 2 patient groups following dose-titration
Results and safety
The study was stopped early (reason given: Failure to recruit people with very late onset schizophrenia like psychosis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne J Reeves, MBChB, PhD principal investigator
Institute of Psychiatry, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patients- dose titration in people with Alzheimer's Disease and Schizophrenia, run by Institute of Psychiatry, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Failure to recruit people with very late onset schizophrenia like psychosis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose titration (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.