NCT01125683

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

9 months

First QC Date

May 13, 2010

Last Update Submit

May 11, 2011

Conditions

Alzheimer´s Disease

Keywords

Phase IIAlzheimer's diseaseEEGcognitionpharmacodynamic

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (3)

  • To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP.

    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

    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.

    Information on these will be collected from the time of informed consent is signed, throughout the study.

Study Arms (5)

1

EXPERIMENTAL

2,5 mg once daily

Drug: AZD1446

2

ACTIVE COMPARATOR

single dose of 5 mg

Drug: Donepezil

3

PLACEBO COMPARATOR
Drug: Placebo

4

EXPERIMENTAL

60 mg once daily

Drug: AZD1446

5

EXPERIMENTAL

60 mg three times daily

Drug: AZD1446

Interventions

AZD1446DRUG

Capsule, oral single and multiple dose

145
DonepezilDRUG

Capsule, oral and single dose

2
PlaceboDRUG

Capsule, oral and single dose

3

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of probable Alzheimer´s Disease
  • Hachinski Ischaemic score \< 4
  • MSE score 18 to 24

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Kazan', Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Kiev, Ukraine, Ukraine

Location

Research Site

Dnipropetrovsk, Ukraine

Location

Research Site

Luhansk, Ukraine

Location

Research Site

Vinnytsia, Ukraine

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octaneDonepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Märta Segerdahl, MD, PhD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 13, 2010

First Posted

May 18, 2010

Study Start

June 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations

UA(4)RU(3)