Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)

NCT ID: NCT01466088

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-05-31

Brief Summary

Alzheimer's disease is the most common form of dementia and is the fourth leading cause of death among people 65 years of age and older. The global prevalence of the disease will increase significantly as the population ages, unless preventative treatments can be identified and marketed. The present study seeks to evaluate AZD3480 (TC-1734) compared to an approved medication (donepezil) shown to improve cognition and function in patients with Alzheimer's disease.

Detailed Description

This is a double blind, positive comparator, randomized, multicenter, parallel group study to assess the efficacy, safety, and tolerability of AZD3480 as monotherapy in patients with mild to moderate dementia of the Alzheimer's type (AD). Approximately 300 subjects will be randomized and divided into 2 cohorts. Actual randomization was 293 subjects.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AZD3480

Group Type: EXPERIMENTAL

AZD3480

Intervention Type: DRUG

Subjects taking 30 mg AZD3480 will take one capsule of AZD3480 and two capsules of placebo for donepezil (to maintain blind) orally once a day.

Donepezil

Donepezil will be administered at 5 mg daily for 4 weeks and escalated to 10 mg daily for the remainder of the study.

Group Type: ACTIVE_COMPARATOR

Donepezil

Intervention Type: DRUG

Subjects taking donepezil will take 1-2 capsules of 5 mg donepezil and a placebo for AZD3480 (to maintain blind) orally once a day.

Interventions

Donepezil

Subjects taking donepezil will take 1-2 capsules of 5 mg donepezil and a placebo for AZD3480 (to maintain blind) orally once a day.

Intervention Type: DRUG

AZD3480

Subjects taking 30 mg AZD3480 will take one capsule of AZD3480 and two capsules of placebo for donepezil (to maintain blind) orally once a day.

Intervention Type: DRUG

Other Intervention Names

Aricept; TC-1734

Eligibility Criteria

Inclusion Criteria

1. A clinical diagnosis of AD per NINCDS-ADRDA criteria; mild to moderate severity as defined by Mini-Mental State Examination (MMSE) scores of 12 to 22.

2. AD diagnosed at least 12 months prior to Screening, and supported by brain imaging studies within 6 months prior to Screening.

3. Absence of vascular dementia both per AIRENS criteria and as defined by modified Hachinski ischemia score (HIS) of </= 4.

4. Presence of a caregiver with significant proportion of time in contact with subject and who will oversee administration of study drug during the trial

5. Able to complete test assessments and to sign informed consent with the help of a caregiver if needed

Exclusion Criteria

1. Diagnosis or presence of other dementing illnesses

2. Use of mood stabilizers, antidepressants, anxiolytics, antipsychotics or hypnotics

3. Treatment within 1 month prior to Screening using cognition-affecting agents (e.g. CNS stimulants)

4. Tobacco user within 4 months prior to Screening

5. Use of smoking cessation therapy within 4 months prior to Screening

6. History within past 6 months of alcohol abuse or illicit drug abuse

7. Unable, even with caregiver assistance, to comply with study procedures in opinion of investigator

8. Myocardial infarction within the 12 months prior to Screening

9. Hypothyroidism, vitamin B12 or folic acid deficiency

10. Known systemic infection (HBV, HCV, HIV, TB)

11. Vascular dementia per NINDS-AIRENS criteria and as defined by a modified Hachinski ischemia score (HIS, Appendix 4) score of > 4 (i.e., vascular dementia is consistent with a modified HIS > 4).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Targacept Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Tariot, MD

Role: PRINCIPAL_INVESTIGATOR

Banner Alzheimer Institute

Locations

Banner Alzheimer Institute

Phoenix, Arizona, United States

Meridien Research

Brooksville, Florida, United States

MD Clinical

Hallandale, Florida, United States

Policlinic

Choceň, , Czechia

BRAIN-SOULTHERAPY s.r.o.

Kladno, , Czechia

Bialbi.s.r.o. Psychiatrické oddělení

Litoměřice, , Czechia

Psychiatricka Ambulance

Olomouc, , Czechia

Vojenska Nemocnice Psychiatricke oddeleni

Olomouc, , Czechia

Clintrial

Prague, , Czechia

PRAGTIS s.r.o.

Prague, , Czechia

Psychosocialni centrum

Přerov, , Czechia

Crucea Alba - Dr. Oros si Asociatii - Societate Civila Medicala

Oradea, , Romania

Spitalul de Psihiatrie Sibiu

Sibiu, , Romania

Spitalul Clinic Judetean de Urgenta SIBIU

Sibiu, , Romania

Spitalul Clinic Judetean de Urgenta, Clinica Psihiatrie

Timișoara, , Romania

Spitalul Clinic Judetean de Urgenta, Clinica Neurologie 2

Timișoara, , Romania

Neurologicka Ambulancia, s.r.o.

Banská Bystrica, , Slovakia

Univerzitna nemocnica Bratislava, Geronto-psychiatrické oddelenie

Bratislava, , Slovakia

KONZILIUM s.r.o.

Dubnica nad Váhom, , Slovakia

Neurologická ambulancia

Krompachy, , Slovakia

Dnipropetrovsk Regional Clinical Hospital

Dnipropetrovsk, , Ukraine

Donetsk National Medical University of M. Gorky

Donetsk, , Ukraine

Donetsk Regional Clinical Psychiatric Hospital

Donetsk, , Ukraine

Crimean Republican Institution Psychoneurological Dispensary

Kerch, , Ukraine

Central Clinical Hospital Ukrzaliznytsi

Kharkiv, , Ukraine

Department of Age Physiology and Pathology of Nervous System; Institute of Gerontology NAMS

Kyiv, , Ukraine

Lugansk Regional Clinical Psychoneurological Hospital

Luhansk, , Ukraine

Lviv National Medical University named after Galytskyy

Lviv, , Ukraine

Lviv Regional Clinical Psychiatric Hospital

Lviv, , Ukraine

Odessa Regional Psychoneurology Dispensary

Odesa, , Ukraine

Odessa Regional Psychiatric Hospital # 2

Oleksandrivka, , Ukraine

Ukrainian Medical Stomatological Academy

Poltava, , Ukraine

Department #3 of the Kherson Regional Psychiatric Hospital

Stepanovka, , Ukraine

Countries

United States; Czechia; Romania; Slovakia; Ukraine

Other Identifiers

TC-1734-226-CRD-006

Identifier Type: -

Identifier Source: org_study_id