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PET Study in Parkinson's Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01527695
First received: December 22, 2011
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
 Drug: ER tablet 25 mg AZD3241
Drug: ER tablet 100 mg AZD3241
Drug: Placebo for AZD3241 25 mg
Drug: Placebo for AZD3241 100 mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET). [ Time Frame: baseline, 2-4 weeks ] [ Designated as safety issue: No ]
  • Change of binding of [11C]PBR28 to TSPO measured by PET. [ Time Frame: baseline, 7-8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Change in plasma activity of myeloperoxidase (MPO). [ Time Frame: baseline, up to 10 weeks ] [ Designated as safety issue: No ]
  • Plasma concentrations of AZD3241. [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Part of safety profile in terms of Columbia Suicide Severity Rating Scale. [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 Drug: ER tablet 25 mg AZD3241
2 tablets twice daily for Day 1
Drug: ER tablet 100 mg AZD3241
1-6 tablets twice daily from Day 2 until Day 56±3 days
Experimental: Placebo
AZD3241 placebo bid for 8 weeks
 Drug: Placebo for AZD3241 25 mg
2 tablets twice daily for Day 1
Drug: Placebo for AZD3241 100 mg
1-6 tablets twice daily from Day 2 until Day 56±3 days

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527695

Locations
Sweden
Reserach Site
Stockholm, Sweden
Research Site
Uppsala, Sweden
Research Site
Vallingby, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Per Svenningsson, MD, PHD Karolinska University Hospital Huddinge, Sweden
Study Director: Bjorn Paulsson, MD AstraZeneca Medical Science Director
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01527695     History of Changes
Other Study ID Numbers: D0490C00004
Study First Received: December 22, 2011
Last Updated: January 30, 2013
Health Authority: Sweden: Medical Products Agency
Finland: Finnish Medicines Agency

Keywords provided by AstraZeneca:
Phase IIa
AZD3241
microglia activation
 safety
Pharmacodynamics and pharmacokinetics analyses
Parkinson patients

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 16, 2013