To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer’s Disease

Overview

The purpose of this study is to evaluate whether treatment with single and multiple oral doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and Event-Related Potentials in patients with Alzheimers Disease. The total treatment period is 9 weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days each.

Full Title of Study: “A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Pharmacodynamic Effect of Single and Multiple Oral Doses of AZD1446/ Placebo and a Single Dose of Donepezil on Quantified Electroencephalography and Event-Related Potentials in Patients With AD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2011

Interventions

  • Drug: AZD1446
    • Capsule, oral single and multiple dose
  • Drug: Donepezil
    • Capsule, oral and single dose
  • Drug: Placebo
    • Capsule, oral and single dose

Arms, Groups and Cohorts

  • Experimental: 1
    • 2,5 mg once daily
  • Active Comparator: 2
    • single dose of 5 mg
  • Placebo Comparator: 3
  • Experimental: 4
    • 60 mg once daily
  • Experimental: 5
    • 60 mg three times daily

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD.
    • Time Frame: collected from the time of informed consent is signed, throughout the study. The total study period is 9 weeks, divided into 5 equally long treatment periods of 7 days and 4 wash-out periods of 7 days each.

Secondary Measures

  • To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP.
    • Time Frame: Information on these will be collected from the time of randomization, throughout the study.
  • To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable
    • Time Frame: Information on these will be collected from the time of informed consent is signed, throughout the study.
  • Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination.
    • Time Frame: Information on these will be collected from the time of informed consent is signed, throughout the study.

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of probable Alzheimer´s Disease – Hachinski Ischaemic score < 4 – MSE score 18 to 24 Exclusion Criteria:

  • History of any clinically significant disease or dementia other than Alzheimer´s Disease – Current major depressive disorder or other major psychiatric disorders

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • MSD, AstraZeneca
  • Overall Official(s)
    • Märta Segerdahl, MD, PhD, Study Director, AstraZeneca

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.