MedTrace Logo

SRC Inhibition as a Potential Target for Parkinson's Disease Psychosis

NCT03661125 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-13

No results posted yet for this study

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. 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.

Conditions

  • Parkinson Disease Psychosis

Interventions

DRUG

Saracatinib

AZD0530 (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 Oral Tablet

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.

Sponsors & Collaborators

Principal Investigators

  • Mitul Mehta · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-11
Primary Completion
2021-09-01
Completion
2021-09-01
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03661125 on ClinicalTrials.gov