Parkinson Disease PsychosisEarly Phase 1SCRIPTNCT03661125
SRC Inhibition as a Potential Target for Parkinson's Disease Psychosis
A Early Phase 1 study testing Saracatinib in people with Parkinson Disease Psychosis, run by King's College London at 1 site in United Kingdom.
Trial summary
Parkinson's disease is often characterised by movement symptoms such as rigidity and bradykinesia, however, there are a number of non-motor symptoms that can have a significant impact on quality of life. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease Psychosis
- What is being tested?
- Saracatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Apr 2019to 1 Sep 2021
- Phase
- Early Phase 1
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the study procedures and agree to participate by providing written informed consent.
- Have a confirmed diagnosis of Parkinson's disease using internationally accepted UK brain bank criteria.
- Be male or female
- Be right handed
- Aged 40 years or over
- Be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12 lead ECG and vital signs measurements performed at screening and prior to administration of the initial dose of study drug.
Show all 9Show fewer
- Have a score of at least 22 on the Montreal Cognitive Assessment (MoCA).
- Have a diagnosis of idiopathic PD with moderate severity
- Have a combined score of at least 6 or an individual score of at least 4 on the neuropsychiatric inventory (NPI [20]) 23 items A (delusions) and/or B (hallucinations).
Who cannot join
- Is a female of child bearing potential
- Is currently taking anticholinergic medication
- Is currently taking any medication known to be a moderate or potent CYP3A4 inducer or inhibitor.
- Has an ongoing disability, medical or neurological history, cognitive impairment, or conditions that in the opinion of the investigator may interfere with study conduct or clinical assessments.
- Refuses to be withdrawn from quetiapine (see section 4.7).
- Has a family history of psychosis in a first degree relative
Show all 27Show fewer
- Has poor peripheral arterial/venous access or recent wrist trauma that will restrict ability to gain venous access.
- Is currently using prescription or non-prescription drugs and herbal supplements, which are deemed to affect the integrity of the study, within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication. As an exception, paracetamol or acetaminophen may be used at doses of 1 g/day.
- Has a history of sensitivity to any of the study medications or any of the excipient constituents.
- Has a history of febrile illness within 5 days prior to the first dose
- Has a hairstyle which would affect EEG recording.
- Has any condition possibly affecting drug absorption (eg, gastrectomy).
- Has a history of regular alcohol consumption exceeding 14 units/week (6 glasses of 13.0% wine (175ml), 6 pints of 4.0% lager or ale (568ml), 5 pints of 4.5% cider (568 ml) or 14 glasses of 10.0% spirits (25ml)) within 6 months of screening.
- Uses tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Uses caffeine containing products of the equivalence of 5 cups of regular filter coffee per day
- Has a positive urine drug screen on or after the screening visit during their active involvement in the study for opiates, methadone, cocaine, amphetamines (including MDMA), barbiturates, benzodiazepines and cannabinoids.
- Is unwilling or unable to comply with the Lifestyle guidelines.
- Has, in the opinion of the investigator, has any medical or psychological condition or social circumstances which would impair their ability to participate reliably in the study, or who may increase the risk to themselves or others by participating.
- Is male and is unwilling to follow the contraception guidance or has a female partner of child bearing potential who is unwilling to follow the contraception guidance throughout the study.
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)
- Total bilirubin > 1.25 x ULN
- Known congenital long QT syndrome
- Baseline resting QTcF > 470ms on 12 lead ECG
- Positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody at screening
- Known to have tested positive for human immunodeficiency virus.
- Participation in another clinical study with an investigational product administered in the last 3 months
- Below the lower limit of normal Hb, total WBC and neutrophils on blood counts as per the reference ranges of the laboratory conducting the tests.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Mitul Mehta
London, Camberwell, SE5 8AF
Mitul Mehta, +44 (0)2032283053, mitul.mehta@kcl.ac.uk
Miriam Vignando, 07492634351, miriam.vignando@kcl.ac.uk
About this study
Official title: A Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis.
Parkinson's disease is often characterised by movement symptoms such as rigidity and bradykinesia, however, there are a number of non-motor symptoms that can have a significant impact on quality of life. One of the most common non-motor symptoms of Parkinson's disease is visual hallucinations (where someone sees things that don't exist outside their mind). . Recent findings led to the approval of a drug called Pimavanserin as a treatment for PD psychosis in the USA. Based on other recent studies, we believe that Saracatinib, a drug that interacts within the same system as Pimavanserin, is a potential treatment for PD psychosis. Saracatinib has shown to reduce the intensity of the psychedelic effect induced by psilocybin (a naturally occurring psychedelic found in psilocybe mushrooms) and attenuate social cognition and brain changes in healthy volunteers. The aim of this study is to test the effects of 14 days dosing of saracatinib or placebo on 30 volunteers with PD psychosis. We aim to to use neuroimaging combined with psychopharmacology to provide evidence that a putative new treatment approach can modulate abnormal visual cortex activation in patients with PD psychosis. If positive, this proof of mechanism study would provide a strong platform to pursue symptom modification studies with Saracatinib.
Read the detailed description
Parkinson's disease (PD) is a neurodegenerative condition which has a 1% prevalence in the over 60s and also affects young adults. As well as motor symptoms such as akinesia or rigidity, many patients also experience non-motor symptoms of which psychosis is the most common (Chang and Fox, 2016). Current treatments for Parkinson's disease psychosis include atypical antipsychotics such as quetiapine, clozapine and pimavanserin (a 5-HT2a inverse agonist). Pimavanserin has recently been approved in the USA as a PD psychosis treatment; it has been shown to have an overall effect on reducing hallucinations as a whole, but not on visual hallucinations specifically. Functional neuroimaging evidence confirms dysfunctional ventral visual pathway activity in PD psychosis with altered metabolism, blood flow and brain activation following visual stimulation (Chang and Fox, 2016). Outside of the ventral visual pathways, two imaging studies in PD patients with visual hallucinations have shown altered connectivity within the default mode network, a brain system implicated in many neuropsychiatric conditions, pointing to more widespread abnormalities (Chang and Fox, 2016). Structural imaging studies show some atrophy within the ventral visual pathways, but also implicates brain regions outside of visual processing areas, including parietal, frontal, and cerebellar and hippocampal regions (Ffytche et al., 2017). Moreover, even though the serotoninergic dysfunction underpinning Parkinson's disease psychosis is not fully understood, animal studies with psychedelics have pointed to the dimerisation of the 5-HT2A and mGlu2 receptors and the over recruitment of specific downstream signalling pathways. Src kinase inhibition is a potential mechanism for blocking the hallucinogenic effects of 5-HT2A receptor agonism. Src kinase inhibitor, Saracatinib, has shown to reduce the intensity of the psychedelic effect induced by psilocybin (a naturally occurring psychedelic found in psilocybe mushrooms (Byock, 2018)) and attenuate social cognition and brain changes in healthy volunteers. We will test the effects of Saracatinib on brain activity associated with visual processing using a visual processing task, known to be sensitive to 5-HT2a receptor stimulation in previous studies with psilocybin (Carter et al., 2004), and a visual recognition task (Meppelink et al., 2009) with known sensitivity to PD psychosis, both scanned using the latest implementation of multi-echo blood oxygen level dependent (BOLD) functional Magnetic Resonance Imaging (fMRI). We aim to conduct a double-blind crossover design study, looking at the effects of Saracatinib and placebo treatment on 26 patients who have PD with psychosis. Existing data shows that 10 days of dosing with Saracatinib will achieve a steady state level that is known to be well tolerated in people with Alzheimer's disease (Nygaard et al., 2015). Therefore, participants will be given an oral dose of 100mg of Saracatinib or placebo as two 50mg tablets to be taken once daily for 14 days. Participants will return to the clinic on day 14 for their final dose of Saracatinib or placebo, fMRI and EEG scans, cognitive assessments, physical examination and blood screen. The participants will then move onto the second treatment arm where they will receive a further 14 days of dosing with saracatinib or placebo depending on the group they were in for the first treatment arm. There will be a minimum 2-week washout between treatment arms to avoid potential carry over effects.
- Conditions
- Parkinson Disease Psychosis
- Being tested
- Saracatinib, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaracatinibDrug
AZD0530 (Saracatinib) 50 mg Tablet Pink Round 7.0 mm ADM P/5406/49. Two tablets to be taken every morning for 14 days.
Placebo Oral TabletDrug
Placebo AZD0530 (Saracatinib) 50 mg Tablet Pink Round 7.0 mm ADM P/5406/37. Two tablets to be taken every morning for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Saracatinib or placebo | Experimental | In the first arm of the study, participants will be randomised into either the group that receives Saracatinib (study drug) or the Placebo. Receives: Drug: Saracatinib; Drug: Placebo Oral Tablet |
| Placebo or Saracatinib (Cross-over) | Experimental | The groups will now cross over i.e. the group that had the study drug in the first arm will get the placebo in the second arm and the group that had the placebo in the first arm will have the study drug in the second arm. Receives: Drug: Saracatinib; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between study drug and placebo in BOLD activity in the ventral visual stream during visual recognition vs. the control task measure using fMRI
Using functional magnetic resonance imaging (fMRI) to look at the effect of saracatinib in attenuating the reduced response in the ventral visual stream on the visual recognition tasks, compared to placebo.
Measured: 2 months (two treatment arms)
Secondary outcomes (2)
Difference between study drug and placebo in BOLD activity in the occipito-temporal region during the visual processing task (Kanisza illusion)
Using functional magnetic resonance imaging (fMRI) to look at the difference in blood oxygen level dependent activity in the occipito-temporal regions between Saracatinib and placebo during a visual processing task that involves looking and making decisions about a visual illusion that involves shapes that create the illusion of edges that do not exist physically
Measured: 2 months (two treatment arms)
Change in Mismatch negativity (MMN) in microvolts (mV) and connectivity with the posterior cingulate hub of the default mode network
Using electroencephalogram (EEG) to look at change in brain activity within specific areas of the brain that are known to work together.
Measured: 2 months (two treatment arms)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start11 Apr 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease PsychosisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Mitul Mehta, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661125
- Sponsor's protocol ID
- 247303
- Acronym
- SCRIPT
- Status last verified
- Aug 2018
- First submitted
- 4 Sep 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our consent procedures include asking for permission to share anonymised data with other researchers. If consent is given then the anonymised data will be added to our database. Currently interested researchers need to apply for accessto our database.
Publications
Nygaard HB, Wagner AF, Bowen GS, Good SP, MacAvoy MG, Strittmatter KA, Kaufman AC, Rosenberg BJ, Sekine-Konno T, Varma P, Chen K, Koleske AJ, Reiman EM, Strittmatter SM, van Dyck CH. A phase Ib multiple ascending dose study of the safety, tolerability, and central nervous system availability of AZD0530 (saracatinib) in Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 14;7(1):35. doi: 10.1186/s13195-015-0119-0. eCollection 2015.
PubMed 25874001Chang A, Fox SH. Psychosis in Parkinson's Disease: Epidemiology, Pathophysiology, and Management. Drugs. 2016 Jul;76(11):1093-118. doi: 10.1007/s40265-016-0600-5.
PubMed 27312429Ffytche DH, Creese B, Politis M, Chaudhuri KR, Weintraub D, Ballard C, Aarsland D. The psychosis spectrum in Parkinson disease. Nat Rev Neurol. 2017 Feb;13(2):81-95. doi: 10.1038/nrneurol.2016.200. Epub 2017 Jan 20.
PubMed 28106066Byock I. Taking Psychedelics Seriously. J Palliat Med. 2018 Apr;21(4):417-421. doi: 10.1089/jpm.2017.0684. Epub 2018 Jan 22.
PubMed 29356590Carter OL, Pettigrew JD, Burr DC, Alais D, Hasler F, Vollenweider FX. Psilocybin impairs high-level but not low-level motion perception. Neuroreport. 2004 Aug 26;15(12):1947-51. doi: 10.1097/00001756-200408260-00023.
PubMed 15305143Meppelink AM, de Jong BM, Renken R, Leenders KL, Cornelissen FW, van Laar T. Impaired visual processing preceding image recognition in Parkinson's disease patients with visual hallucinations. Brain. 2009 Nov;132(Pt 11):2980-93. doi: 10.1093/brain/awp223. Epub 2009 Sep 15.
PubMed 19755518
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis.
- ClinicalTrials.gov ID
- NCT03661125
- Acronym / sponsor ID
- SCRIPT / 247303
- Conditions
- Parkinson Disease Psychosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- AstraZeneca, King's College Hospital NHS Trust
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 7 Sep 2018 (actual)
- 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.
Parkinson's disease is often characterised by movement symptoms such as rigidity and bradykinesia, however, there are a number of non-motor symptoms that can have a significant impact on quality of life. One of the most common non-motor symptoms of Parkinson's disease is visual hallucinations (where someone sees things that don't exist outside their mind). . Recent findings led to the approval of a drug called Pimavanserin as a treatment for PD psychosis in the USA. Based on other recent studies, we believe that Saracatinib, a drug that interacts within the same system as Pimavanserin, is a potential treatment for PD psychosis. Saracatinib has shown to reduce the intensity of the psychedelic effect induced by psilocybin (a naturally occurring psychedelic found in psilocybe mushrooms) and attenuate social cognition and brain changes in healthy volunteers. The aim of this study is to test the effects of 14 days dosing of saracatinib or placebo on 30 volunteers with PD psychosis. We aim to to use neuroimaging combined with psychopharmacology to provide evidence that a putative new treatment approach can modulate abnormal visual cortex activation in patients with PD psychosis. If positive, this proof of mechanism study would provide a strong platform to pursue symptom modification studies with Saracatinib.
Detailed description
Parkinson's disease (PD) is a neurodegenerative condition which has a 1% prevalence in the over 60s and also affects young adults. As well as motor symptoms such as akinesia or rigidity, many patients also experience non-motor symptoms of which psychosis is the most common (Chang and Fox, 2016). Current treatments for Parkinson's disease psychosis include atypical antipsychotics such as quetiapine, clozapine and pimavanserin (a 5-HT2a inverse agonist). Pimavanserin has recently been approved in the USA as a PD psychosis treatment; it has been shown to have an overall effect on reducing hallucinations as a whole, but not on visual hallucinations specifically. Functional neuroimaging evidence confirms dysfunctional ventral visual pathway activity in PD psychosis with altered metabolism, blood flow and brain activation following visual stimulation (Chang and Fox, 2016). Outside of the ventral visual pathways, two imaging studies in PD patients with visual hallucinations have shown altered connectivity within the default mode network, a brain system implicated in many neuropsychiatric conditions, pointing to more widespread abnormalities (Chang and Fox, 2016). Structural imaging studies show some atrophy within the ventral visual pathways, but also implicates brain regions outside of visual processing areas, including parietal, frontal, and cerebellar and hippocampal regions (Ffytche et al., 2017). Moreover, even though the serotoninergic dysfunction underpinning Parkinson's disease psychosis is not fully understood, animal studies with psychedelics have pointed to the dimerisation of the 5-HT2A and mGlu2 receptors and the over recruitment of specific downstream signalling pathways. Src kinase inhibition is a potential mechanism for blocking the hallucinogenic effects of 5-HT2A receptor agonism. Src kinase inhibitor, Saracatinib, has shown to reduce the intensity of the psychedelic effect induced by psilocybin (a naturally occurring psychedelic found in psilocybe mushrooms (Byock, 2018)) and attenuate social cognition and brain changes in healthy volunteers. We will test the effects of Saracatinib on brain activity associated with visual processing using a visual processing task, known to be sensitive to 5-HT2a receptor stimulation in previous studies with psilocybin (Carter et al., 2004), and a visual recognition task (Meppelink et al., 2009) with known sensitivity to PD psychosis, both scanned using the latest implementation of multi-echo blood oxygen level dependent (BOLD) functional Magnetic Resonance Imaging (fMRI). We aim to conduct a double-blind crossover design study, looking at the effects of Saracatinib and placebo treatment on 26 patients who have PD with psychosis. Existing data shows that 10 days of dosing with Saracatinib will achieve a steady state level that is known to be well tolerated in people with Alzheimer's disease (Nygaard et al., 2015). Therefore, participants will be given an oral dose of 100mg of Saracatinib or placebo as two 50mg tablets to be taken once daily for 14 days. Participants will return to the clinic on day 14 for their final dose of Saracatinib or placebo, fMRI and EEG scans, cognitive assessments, physical examination and blood screen. The participants will then move onto the second treatment arm where they will receive a further 14 days of dosing with saracatinib or placebo depending on the group they were in for the first treatment arm. There will be a minimum 2-week washout between treatment arms to avoid potential carry over effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saracatinib or placebo | Experimental | Drug: Saracatinib, Drug: Placebo Oral TabletIn the first arm of the study, participants will be randomised into either the group that receives Saracatinib (study drug) or the Placebo. |
| Placebo or Saracatinib (Cross-over) | Experimental | Drug: Saracatinib, Drug: Placebo Oral TabletThe groups will now cross over i.e. the group that had the study drug in the first arm will get the placebo in the second arm and the group that had the placebo in the first arm will have the study drug in the second arm. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Understand the study procedures and agree to participate by providing written informed consent.
- Have a confirmed diagnosis of Parkinson's disease using internationally accepted UK brain bank criteria.
- Be male or female
- Be right handed
- Aged 40 years or over
Key exclusion criteria (27 listed)
- Is a female of child bearing potential
- Is currently taking anticholinergic medication
- Is currently taking any medication known to be a moderate or potent CYP3A4 inducer or inhibitor.
- Has an ongoing disability, medical or neurological history, cognitive impairment, or conditions that in the opinion of the investigator may interfere with study conduct or clinical assessments.
- Refuses to be withdrawn from quetiapine (see section 4.7).
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 |
|---|---|---|
| SaracatinibAZD0530 (Saracatinib) 50 mg Tablet Pink Round 7.0 mm ADM P/5406/49. Two tablets to be taken every morning for 14 days. | Drug | Placebo or Saracatinib (Cross-over), Saracatinib or placebo |
| Placebo Oral TabletPlacebo AZD0530 (Saracatinib) 50 mg Tablet Pink Round 7.0 mm ADM P/5406/37. Two tablets to be taken every morning for 14 days. | Drug | Placebo or Saracatinib (Cross-over), Saracatinib or placebo |
Primary outcome
Difference between study drug and placebo in BOLD activity in the ventral visual stream during visual recognition vs. the control task measure using fMRI
Time frame: 2 months (two treatment arms)
Using functional magnetic resonance imaging (fMRI) to look at the effect of saracatinib in attenuating the reduced response in the ventral visual stream on the visual recognition tasks, compared to placebo.
2 secondary outcomes
Difference between study drug and placebo in BOLD activity in the occipito-temporal region during the visual processing task (Kanisza illusion)
Time frame: 2 months (two treatment arms)
Change in Mismatch negativity (MMN) in microvolts (mV) and connectivity with the posterior cingulate hub of the default mode network
Time frame: 2 months (two treatment arms)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Background: PubMed 25874001Nygaard HB, Wagner AF, Bowen GS, Good SP, MacAvoy MG, Strittmatter KA, Kaufman AC, Rosenberg BJ, Sekine-Konno T, Varma P, Chen K, Koleske AJ, Reiman EM, Strittmatter SM, van Dyck CH. A phase Ib multiple ascending dose study of the safety, tolerability, and central nervous system availability of AZD0530 (saracatinib) in Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 14;7(1):35. doi: 10.1186/s13195-015-0119-0. eCollection 2015.
- Background: PubMed 27312429Chang A, Fox SH. Psychosis in Parkinson's Disease: Epidemiology, Pathophysiology, and Management. Drugs. 2016 Jul;76(11):1093-118. doi: 10.1007/s40265-016-0600-5.
- Background: PubMed 28106066Ffytche DH, Creese B, Politis M, Chaudhuri KR, Weintraub D, Ballard C, Aarsland D. The psychosis spectrum in Parkinson disease. Nat Rev Neurol. 2017 Feb;13(2):81-95. doi: 10.1038/nrneurol.2016.200. Epub 2017 Jan 20.
- Background: PubMed 29356590Byock I. Taking Psychedelics Seriously. J Palliat Med. 2018 Apr;21(4):417-421. doi: 10.1089/jpm.2017.0684. Epub 2018 Jan 22.
- Background: PubMed 15305143Carter OL, Pettigrew JD, Burr DC, Alais D, Hasler F, Vollenweider FX. Psilocybin impairs high-level but not low-level motion perception. Neuroreport. 2004 Aug 26;15(12):1947-51. doi: 10.1097/00001756-200408260-00023.
- Background: PubMed 19755518Meppelink AM, de Jong BM, Renken R, Leenders KL, Cornelissen FW, van Laar T. Impaired visual processing preceding image recognition in Parkinson's disease patients with visual hallucinations. Brain. 2009 Nov;132(Pt 11):2980-93. doi: 10.1093/brain/awp223. Epub 2009 Sep 15.
- Individual participant dataSharing planned: Yes. Our consent procedures include asking for permission to share anonymised data with other researchers. If consent is given then the anonymised data will be added to our database. Currently interested researchers need to apply for accessto our database.
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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.
Mitul Mehta principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Saracatinib in people with Parkinson Disease Psychosis, run by King's College 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 9 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 13 Aug 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Vignando (+44 (0) 7492634351, miriam.vignando@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between study drug and placebo in BOLD activity in the ventral visual stream during visual recognition vs. the control task measure using fMRI (time frame: 2 months (two treatment arms)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03661125, which also lists 6 linked publications.
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 13 Aug 2019.