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

May 11, 2015 updated by: Targacept Inc.

Double-Blind, Positive Comparator, Randomized, Parallel Study of Efficacy, Safety, and Tolerability of AZD3480 (TC-1734-226) as Monotherapy in Patients With Mild to Moderate Dementia of the Alzheimer's Type

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

386

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Chocen, Czech Republic
        • Policlinic
      • Kladno, Czech Republic
        • BRAIN-SOULTHERAPY s.r.o.
      • Litoměřice, Czech Republic
        • Bialbi.s.r.o. Psychiatrické oddělení
      • Olomouc, Czech Republic
        • Psychiatricka ambulance
      • Olomouc, Czech Republic
        • Vojenska Nemocnice Psychiatricke oddeleni
      • Praha, Czech Republic
        • Clintrial
      • Praha, Czech Republic
        • PRAGTIS s.r.o.
      • Prerov, Czech Republic
        • Psychosocialni Centrum
  • Romania
      • Oradea, Romania, 410163
        • Crucea Alba - Dr. Oros si Asociatii - Societate Civila Medicala
      • Sibiu, Romania, 550012
        • Spitalul de Psihiatrie Sibiu
      • Sibiu, Romania, 550166
        • Spitalul Clinic Judetean de Urgenta Sibiu
      • Timisoara, Romania, 300128
        • Spitalul Clinic Judetean de Urgenta, Clinica Psihiatrie
      • Timisoara, Romania, 300736
        • Spitalul Clinic Judetean de Urgenta, Clinica Neurologie 2
  • Slovakia
      • Banska Bystrica, Slovakia
        • Neurologicka Ambulancia, s.r.o.
      • Bratislava, Slovakia
        • Univerzitna nemocnica Bratislava, Geronto-psychiatrické oddelenie
      • Dubnica nad Váhom, Slovakia
        • KONZILIUM s.r.o.
      • Krompachy, Slovakia
        • Neurologická ambulancia
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • Dnipropetrovsk Regional Clinical Hospital
      • Donetsk, Ukraine, 83003
        • Donetsk National Medical University of M. Gorky
      • Donetsk, Ukraine, 83008
        • Donetsk Regional Clinical Psychiatric Hospital
      • Kerch, Ukraine, 98310
        • Crimean Republican Institution Psychoneurological Dispensary
      • Kharkiv, Ukraine, 61103
        • Central Clinical Hospital Ukrzaliznytsi
      • Kyiv, Ukraine, 04114
        • Department of Age Physiology and Pathology of Nervous System; Institute of Gerontology NAMS
      • Lugansk, Ukraine, 91045
        • Lugansk Regional Clinical Psychoneurological Hospital
      • Lviv, Ukraine, 79021
        • Lviv Regional Clinical Psychiatric Hospital
      • Lviv, Ukraine, 79010
        • Lviv National Medical University named after Galytskyy
      • Odessa, Ukraine, 65014
        • Odessa Regional Psychoneurology Dispensary
      • Oleksandrivka, Ukraine, 67513
        • Odessa Regional Psychiatric Hospital # 2
      • Poltava, Ukraine, 36006
        • Ukrainian Medical Stomatological Academy
      • Stepanovka, Ukraine, 73488
        • Department #3 of the Kherson Regional Psychiatric Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer Institute
    • Florida
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AZD3480
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.
Other Names:
  • TC-1734
ACTIVE_COMPARATOR: Donepezil
Donepezil will be administered at 5 mg daily for 4 weeks and escalated to 10 mg daily for the remainder of the study.
Drug: 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.
Other Names:
  • Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
Time Frame: 52 weeks
52 weeks
Change from baseline in the Clinician Interview-Based Impression of Change plus carer interview [CIBIC-(+)]
Time Frame: 52 Weeks
The CIBIC-(+) is a co-primary endpoint with the ADAS-Cog in the United States.
52 Weeks
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time Frame: 52 Weeks
The ADCS-ADL is the co-primary endpoint with the ADAS-Cog in Europe.
52 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the Neuropsychiatric Inventory (NPI)
Time Frame: 52 Weeks
52 Weeks
Change from baseline in the Mini-Mental State Examination (MMSE)
Time Frame: 52 Weeks
52 Weeks
Change from baseline in the Alzheimer's Disease Related Quality of Life (ADRQL)
Time Frame: 52 Weeks
52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Targacept Inc.

Investigators

  • Principal Investigator: Pierre Tariot, MD, Banner Alzheimer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

November 2, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (ESTIMATE)

November 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC-1734-226-CRD-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on AZD3480

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe