NCT03661125: SCRIPT

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

Status unknown EARLY_PHASE1 Last updated 13 August 2019

What this trial tests

EARLY_PHASE1 trial testing Saracatinib in Parkinson Disease Psychosis in 30 participants. Status unknown.

Timeline

11 April 2019

Primary endpoint
1 September 2021

1 September 2021

Quick facts

Lead sponsor	King's College London
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	basic science
Enrollment	30
Start date	11 April 2019
Primary completion	1 September 2021
Estimated completion	1 September 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• Saracatinib — full drug profile →
• Placebo Oral Tablet — full drug profile →

Conditions studied

• Parkinson Disease Psychosis — all drugs for Parkinson Disease Psychosis →

Sponsor

King's College London

Who can join

40 and older, any sex, with Parkinson Disease Psychosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Kinase Inhibitors as Underexplored Antiviral Agents.
   García-Cárceles J, Caballero E, Gil C, Martínez A. · · 2022 · cited 62× · PMID 33970631 · DOI 10.1021/acs.jmedchem.1c00302
2. GSK-3β, FYN, and DYRK1A: Master Regulators in Neurodegenerative Pathways.
   Demuro S, Di Martino RMC, Ortega JA, Cavalli A. · · 2021 · cited 57× · PMID 34445804 · DOI 10.3390/ijms22169098
3. Src Family Kinases in the Central Nervous System: Their Emerging Role in Pathophysiology of Migraine and Neuropathic Pain.
   Nie L, Ye WR, Chen S, Chirchiglia D, et al · · 2021 · cited 21× · PMID 32798375 · DOI 10.2174/1570159x18666200814180218
4. Inhibition of Protein Aggregation and Endoplasmic Reticulum Stress as a Targeted Therapy for α-Synucleinopathy.
   Siwecka N, Saramowicz K, Galita G, Rozpędek-Kamińska W, et al · · 2023 · cited 19× · PMID 37631265 · DOI 10.3390/pharmaceutics15082051
5. Neuroprotective effect of Src kinase in hypoxia-ischemia: A systematic review.
   Christidis P, Vij A, Petousis S, Ghaemmaghami J, et al · · 2022 · cited 3× · PMID 36507364 · DOI 10.3389/fnins.2022.1049655