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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
  Purpose

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.


Condition Intervention Phase
Alzheimer´s Disease
Drug: AZD1446
Drug: Donepezil
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome 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. ] [ Designated as safety issue: No ]

Secondary Outcome 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. ] [ 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 ]

Estimated Enrollment: 40
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
2,5 mg once daily
Drug: AZD1446
Capsule, oral single and multiple dose
Active Comparator: 2
single dose of 5 mg
Drug: Donepezil
Capsule, oral and single dose
Placebo Comparator: 3 Drug: Placebo
Capsule, oral and single dose
Experimental: 4
60 mg once daily
Drug: AZD1446
Capsule, oral single and multiple dose
Experimental: 5
60 mg three times daily
Drug: AZD1446
Capsule, oral single and multiple dose

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125683

Locations
Russian Federation
Research Site
Kazan, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
St. Petersburg, Russian Federation
Ukraine
Research Site
Dnipropetrovsk, Ukraine
Research Site
Kiev, Ukraine
Research Site
Lugansk, Ukraine
Research Site
Vinnytsia, Ukraine
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Märta Segerdahl, MD, PhD AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01125683     History of Changes
Other Study ID Numbers: D1950C00011, 2010-018273-38
Study First Received: May 13, 2010
Last Updated: May 11, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:
Phase II
Alzheimer's disease
EEG
cognition
pharmacodynamic

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014