A Multi-centre, Double-blind, Double-Dummy, Placebo-controlled, Parallel Group, Randomised, Phase IIb Proof of Concept Study with 3 oral dose groups of AZD3480 or donepezil during 12 weeks treatment in patients with Alzheimer’s Disease

Phase 1

• Conditions: Alzheimer's Disease; MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease

• Registration Number: EUCTR2007-000835-24-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-08-01
• Study Start: 2009-01-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 625

Inclusion Criteria

1. Provision of written informed consent before initiation of any study related procedures. Patients who are deemed incapable of providing informed consent may be enrolled if written informed consent has been obtained from the patient’s Legally Acceptable Representative in accordance with local regulations

2. Provision of written informed consent from the caregiver

3. Female and male, aged 60 to 85 years, at day of enrolment

4. Clinical diagnosis of probable AD according to the NINCDS-ADRDA criteria

5. Computerised tomography (CT) or Magnetic resonance imaging (MRI) scan within the past 2 years (performed after onset of dementia) consistent with the diagnosis of AD

6. MMSE score of 12-26

7. Lives with appropriate caregiver at home, or in a community dwelling with caregiver capable of accompanying patient on all clinic visits and visiting the patient at least three times per week for the duration of the study

8. Patient and caregiver understand, speak and read local language

9. Be able to understand and comply with the requirements of the study, as judged by the investigator.

For inclusion in the optional exploratory genetic research at Visit 4, patients must fulfil the following criterion:
1. Provision of informed consent for optional exploratory genetic research. Patients
who are deemed incapable of providing informed consent may be enrolled if written
informed consent has been obtained from the patient’s Legally Authorised
Representative in accordance with local regulations

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Significant neurological disease or dementia other than AD, e.g. Parkinson Disease Dementia, that may affect cognition or ability to complete the study

2. Current major depressive disorder or other major psychiatric disorders according to the DSM-IV criteria

3. Use of AChEIs or memantine for treatment of AD within 8 weeks prior to Visit 1 (enrolment visit) and during the study (except investigational drug after randomisation)

4. Use of smoking cessation therapy within 4 weeks prior to Visit 1 (enrolment visit) and during the study. Smoking cessation therapy include bupropion, varenicline and any dosage form of nicotine replacement therapy

5. Use of certain drugs with narrow therapeutic range, specified in Section 3.7, from Visit 1 (enrolment visit) and during the study. Exception for amiodarone, which is not allowed within 10 weeks of enrolment

6. Use of Ginkgo Biloba and certain concomitant therapy with anticholinergic effect, specified in Section 3.7, unless on a constant stable dose during the last 4 weeks prior to Visit 1 (enrolment visit) and during the study

7. Not suitable for donepezil treatment according to current country-specific label

8. Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, gastrointestinal disease or other major disease as judged by the investigator.

9. Myocardial infarction or acute coronary syndrome within the last year

10. Having a known or suspected hypothyreosis, vitamin B12 or folic acid deficiency as judged by the investigator. Patients with substituted hypothyreosis or vitamin B12 or folic acid deficiency and laboratory values within normal limits can be included

11. Poorly controlled hypertension as judged by the investigator

12. Patients with diabetes mellitus with the exception of stable diabetes controlled on diet alone for at least 3 months before Visit 1 (enrolment visit), as judged by the investigator.

13. Having known or suspected systemic infection (e.g. Hepatitis B virus [HBV], Hepatitis C virus [HCV], Human immunodeficiency virus [HIV], tuberculosis) as judged by the investigator

14. Current systemic illness that, in the judgment of the investigator, is likely to deteriorate or affect the patient’s safety, influence cognitive assessments or affect ability to complete the study

15. History of any malignant disease within the past 5 years with the exception of minor superficial skin diseases (i.e., basal cell carcinoma and squamous cell carcinoma)

16. Impaired vision and hearing making cognitive testing difficult as judged by the investigator

17. Known or suspected drug or alcohol abuse as judged by the investigator

18. Clinically significant ECG abnormalities as judged by the investigator based on assessment by a centrally located experienced cardiologist interpreting the ECG

19. Clinically significant abnormal laboratory values as judged by the investigator

20. Clinically significant abnormal findings in physical examination or vital signs as judged by the investigator

21. Previous bone marrow or stem cell transplant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified