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OpenTrials
Completed

NCT Number: NCT01039701

4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease

The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.

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Key information

Conditions

Mild to Moderate Alzheimer's Disease

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Litoměřice, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • history of progressive worsening of memory and other cognitive functions for at least 12 months
  • treatment with stable dose of donepezil (10 mg) for at least 3 months
  • the patient should have an appropriate caregiver, who is required for all study visits

Exclusion criteria

  • history of allergy/hypersensitivity reactions
  • significant neurological disease or dementia other than Alzheimer's disease
  • myocardial infarction or acute coronary syndrome within the last year

Treatment and study plan

AZD1446

Drug

capsules, oral, 3 times daily

Placebo

Drug

capsules, oral, 3 times daily, 4 weeks

Primary outcomes

  1. Nature and incidence of adverse events

    Time frame: From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur.

Secondary outcomes

  1. To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil

    Time frame: Twice during the study: at Visit 2 and Visit 10.

  2. To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients

    Time frame: Twice during the study: at Visit 8 and Visit 10.

  3. To explore the effects of 3 dose regimens of AZD1446 compared to placebo as an add-on treatment to donepezil on changes in global functioning using ADCS-CGIC

    Time frame: Baseline assessment at Visit 2 and a follow-up assessment at Visit 10

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Safety, Tolerability and Pharmacokinetics of 3 Dose Regimens of AZD1446 vs. Placebo as an Add-on Treatment to Donepezil: A Multi-centre, Double-blind, Randomised, Placebo Controlled, Parallel Group Phase IIa Study in Patients With Mild to Moderate Alzheimer's Disease During 4 Weeks of Treatment

Acronym: ROBIN

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 25, 2009
Registry last updated
Aug 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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