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PET Study in Parkinson's Disease Patients

NCT ID: NCT01527695

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-01-31

Brief Summary

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This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20 patients to complete this study.The study will evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured via PET examinations.

Detailed Description

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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

Conditions

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Parkinson's Disease

Keywords

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Phase IIa AZD3241 microglia activation safety Pharmacodynamics and pharmacokinetics analyses Parkinson patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD3241

AZD3241 tablets 25 mg or 100 mg, titration first 5 days (50 mg bd on Day 1, 100 mg bd on Day 2, 200 mg bd on Day 3, 300 mg bd on Day 4, 400 mg bd on Day 5) Maintenance treatment from Day 6, 600 mg bd until Day 56±3 days

Group Type EXPERIMENTAL

ER tablet 25 mg AZD3241

Intervention Type DRUG

2 tablets twice daily for Day 1

ER tablet 100 mg AZD3241

Intervention Type DRUG

1-6 tablets twice daily from Day 2 until Day 56±3 days

Placebo

AZD3241 placebo bid for 8 weeks

Group Type EXPERIMENTAL

Placebo for AZD3241 25 mg

Intervention Type DRUG

2 tablets twice daily for Day 1

Placebo for AZD3241 100 mg

Intervention Type DRUG

1-6 tablets twice daily from Day 2 until Day 56±3 days

Interventions

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ER tablet 25 mg AZD3241

2 tablets twice daily for Day 1

Intervention Type DRUG

ER tablet 100 mg AZD3241

1-6 tablets twice daily from Day 2 until Day 56±3 days

Intervention Type DRUG

Placebo for AZD3241 25 mg

2 tablets twice daily for Day 1

Intervention Type DRUG

Placebo for AZD3241 100 mg

1-6 tablets twice daily from Day 2 until Day 56±3 days

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Svenningsson, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Bjorn Paulsson, MD

Role: STUDY_DIRECTOR

AstraZeneca Medical Science Director

Locations

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Reserach Site

Stockholm, , Sweden

Site Status

Research Site

Uppsala, , Sweden

Site Status

Research Site

Vällingby, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D0490C00004

Identifier Type: -

Identifier Source: org_study_id