Parkinson's Disease
Conditions
Interventions
Product Name: AZD3241 Extended release tablets 25 mg
Product Code: AZD3241
Pharmaceutical Form: Prolonged-release film-coated tablet
Current Sponsor code: AZD3241
Concentration unit: mg milligram(s)
C
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male patients aged 45 to 75 years (inclusive) at the day of enrolment (Visit 1) 2. Female patients must have a negative pregnancy test at Screening, must not be lactating and must be of non childbearing potential, confirmed at Screening 3. Male patients should be willing to use barrier contraception, eg, condoms, even if their partners are post-menopausal, be surgically sterile or are using accepted contraceptive methods, from the administration of the first dose of the investigational 4. The clinical diagnosis of patients must meet the criteria for “diagnosis of idiopathic Parkinson’s disease” according to the modified UKPDS Brain Bank criteria 5. Modified Hoehn and Yahr stage 1 to 2 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes or heredodegenerative diseases 2. Patients who have undergone surgery for the treatment of Parkinson’s disease (eg, pallidotomy, deep brain stimulation, foetal tissue transplantation) or have undergone any other brain surgery 3. Presence of significant dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes 4. Patients with a history of non-response (according to both the clinician and the patient) to an adequate course of L-dopa or a DA agonist 5. Use of pergolide, selegiline, metoclopramide, strong CYP3A4 inhibitors, CYP3A4 inducers (including St John’s Wort) and strong CYP1A2 inhibitors and inducers, within 1 month of randomisation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured by [11C]PBR28 binding to TSPO. ;Secondary Objective: To evaluate safety and tolerability of AZD3241 in patients with Parkinson’s disease To evaluate the pharmacodynamic (PD) effect of AZD3241 by assessment of plasma activity of MPO To explore the pharmacokinetics (PK) of AZD3241 in Parkinson's Diease ;Primary end point(s): To evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured by [11C]PBR28 binding to TSPO.;Timepoint(s) of evaluation of this end point: Baseline PET: Between Day-12 and -5, PET 2: Between week 2 and 4, PET 3: Between week 7 and 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Adverse events, vital signs, ECG, physical examination, weight, clinical chemistry tests 2. To evaluate the pharmacodynamic (PD) effect of AZD3241 by assessment of plasma activity of MPO 3. To explore the pharmacokinetics (PK) of AZD3241 in Parkinson’s disease;Timepoint(s) of evaluation of this end point: 1. Day-28 until Follow-up on week 10 following randomization 2. Between Day- 28-Day -14, randomization, between week 2 and 4, week 4, between week 7-8, follow-up (10 weeks following randomization) 3. Randomization, between week 2 and 4, week 4, between week 7-8 | — |
Countries
Finland, Sweden
Contacts
Public ContactClinical Study Information
AstraZeneca
Outcome results
None listed