A study to investigate the effects of repeated low doses of psilocybin and ketamine on cognitive and emotional dysfunctions in Parkinson’s disease and to understand its mechanism of actio

Phase 1

• Conditions: Parkinson's disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000041-40-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-10
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

-At least 18 years of age
-Being diagnosed with Parkinson’s disease, and able to provide evidence for this (e.g., letter from a medical doctor or DaT-scan)
-Underwent a DaT scan as part of the diagnostic process
-Being able to provide details about the duration of the disease or provide medical records
-Free from conventional Parkinson medication (i.e., Levodopa, dopamine agonist, amantadine, adenosine a2a antagonist, COMT inhibitors, anticholinergic drugs, MAO inhibitors)
-The participant is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
-A resting pulse and heart rate (as read on the ECG) =51 bpm and =100 bpm. For participants in good physical condition, the lower limit is =45 bpm.
-A resting systolic blood pressure =91 mmHg and =140 mmHg and a resting diastolic blood pressure =51 mmHg and =90 mmHg.
-Clinical laboratory test values within clinical reference ranges at screening. Borderline values may be accepted if they are, in the opinion of the investigator, clinically insignificant.
-Normal binocular visual acuity, corrected or uncorrected
-Absence of any major medical, endocrine and neurological condition (apart from Parkinson’s disease), as determined by the medical history, medical examination, electrocardiogram and laboratory analyses (haematology, clinical chemistry, urinalysis, serology).
-Normal weight, body mass index (weight/height2) between 19,5 and 28 kg/m2
-Being able to communicate in Dutch or English
-Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks)
-Use of conventional Parkinson’s disease medication (i.e., Levodopa, dopamine agonist, amantadine, adenosine a2a antagonist, COMT inhibitors, anticholinergic drugs, MAO inhibitors)
-Use of other psychiatric medication
-History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
-Depression or dementia
-Excessive alcohol consumption (>20 units a week)
-Excessive smoking (>20 cigarettes a week)
-Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
-Hypertension (diastolic >90; systolic >140)
-Liver dysfunction
-History of cardiac dysfunctions (arrhythmia, ischemic heart disease, etc)
-Pregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified