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

This study has been terminated.
(Poor recruitment.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01125683
First received: May 13, 2010
Last updated: May 11, 2011
Last verified: May 2011

May 13, 2010
May 11, 2011
June 2010
March 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01125683 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Alzheimer´s Disease
  • Drug: AZD1446
    Capsule, oral single and multiple dose
  • Drug: Donepezil
    Capsule, oral and single dose
  • Drug: Placebo
    Capsule, oral and single dose
  • Experimental: 1
    2,5 mg once daily
    Intervention: Drug: AZD1446
  • Active Comparator: 2
    single dose of 5 mg
    Intervention: Drug: Donepezil
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
  • Experimental: 4
    60 mg once daily
    Intervention: Drug: AZD1446
  • Experimental: 5
    60 mg three times daily
    Intervention: Drug: AZD1446
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   Ukraine
 
NCT01125683
D1950C00011, 2010-018273-38
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Märta Segerdahl, MD, PhD AstraZeneca
AstraZeneca
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP