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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
386

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Targacept Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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