PET Study in Parkinson's Disease Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01527695
• Date of registration: 22/12/2011
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: PET Study in Parkinson's Disease Patients
• Scientific title: A Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's Disease
• Date of first enrolment: April 2012
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01527695
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
• Phase: Phase 2

Countries of recruitment

Sweden

Contacts

• Name: Bjorn Paulsson, MD
• Affiliation: AstraZeneca Medical Science Director

• Name: Per Svenningsson, MD, PHD
• Affiliation: Karolinska University Hospital, Huddinge, Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female and male patients aged 45 to 75 years (inclusive) at the day of enrolment
(Visit 1)

- Female patients must have a negative pregnancy test at Screening, must not be
lactating and must be of non childbearing potential, confirmed at Screening

- 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

- The clinical diagnosis of patients must meet the criteria for "diagnosis of
idiopathic Parkinson's disease" according to the modified UKPDS Brain Bank criteria
(see Appendix E)

- Modified Hoehn and Yahr stage 1 to 2

Exclusion Criteria:

- 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

- 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

- Presence of significant dyskinesias, motor fluctuations, swallowing difficulties or
loss of postural reflexes 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

- 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;



Age minimum: 45 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo for AZD3241 100 mg

Drug: Placebo for AZD3241 25 mg

Drug: ER tablet 25 mg AZD3241

Drug: ER tablet 100 mg AZD3241

Primary Outcome(s)

Change of binding of [11C]PBR28 to TSPO measured by PET. [Time Frame: baseline, 7-8 weeks]

Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET). [Time Frame: baseline, 2-4 weeks]

Secondary Outcome(s)

Adverse events, vital signs, electrocardiogram (ECG), physical examination, clinical chemistry tests, height and weight measures for safety and tolerability profile. [Time Frame: Up to 10 weeks]

Plasma concentrations of AZD3241. [Time Frame: Up to 8 weeks]

Part of safety profile in terms of Columbia Suicide Severity Rating Scale. [Time Frame: Up to 10 weeks]

Change in plasma activity of myeloperoxidase (MPO). [Time Frame: baseline, up to 10 weeks]

Secondary ID(s)

D0490C00004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors