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

NCT01039701 | Completed Phase 2

• 1 other identifier: D1950C00006
• Study Type: interventional
• Target: 99
• Locations: 3 countries
• Sites: 12

Brief Summary

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.

Conditions

Mild to Moderate Alzheimer's Disease

Keywords

safety; tolerability; mild to moderate Alzheimer's disease; To determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil in patients with mild to moderate Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Nature and incidence of adverse events

  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 (3)

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

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

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

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

• 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

  Baseline assessment at Visit 2 and a follow-up assessment at Visit 10

Study Arms (4)

1

EXPERIMENTAL

AZD1446 60mg once daily + donepezil 10mg

Drug: AZD1446

2

EXPERIMENTAL

AZD1446 60mg three times daily + donepezil 10mg

Drug: AZD1446

3

EXPERIMENTAL

AZD1446 30mg three times daily + donepezil 10mg

Drug: AZD1446

4

PLACEBO COMPARATOR

placebo + donepezil 10mg

Drug: Placebo

Interventions

AZD1446 DRUG

capsules, oral, 3 times daily

1; 2; 3

Placebo DRUG

capsules, oral, 3 times daily, 4 weeks

4

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

Research Site

Litoměřice, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Praha 10 - Strasnice, Czechia

Location

Research Site

Debrecen, Hungary

Location

Research Site

Esztergom, Hungary

Location

Research Site

Miskolc, Hungary

Location

Research Site

Nagykálló, Hungary

Location

Research Site

Nyíregyháza, Hungary

Location

Research Site

Szeged, Hungary

Location

Research Site

Bratislava, Slovakia

Location

Research Site

Rožňava, Slovakia

Location

Research Site

Zlaté Moravce, Slovakia

Location

MeSH Terms

Interventions

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2009
• First Posted: December 25, 2009
• Study Start: December 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 11, 2010

Record last verified: 2010-08

Locations

HU (6); CZ (3); SL (3)