Skip to main content
OpenTrials
Completed

NCT Number: NCT01466088

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Policlinic, Choceň, Czechia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • AD diagnosed at least 12 months prior to Screening, and supported by brain imaging studies within 6 months prior to Screening.
  • Absence of vascular dementia both per AIRENS criteria and as defined by modified Hachinski ischemia score (HIS) of </= 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
  • Able to complete test assessments and to sign informed consent with the help of a caregiver if needed

Exclusion criteria

  • Diagnosis or presence of other dementing illnesses
  • Use of mood stabilizers, antidepressants, anxiolytics, antipsychotics or hypnotics
  • Treatment within 1 month prior to Screening using cognition-affecting agents (e.g. CNS stimulants)
  • Tobacco user within 4 months prior to Screening
  • Use of smoking cessation therapy within 4 months prior to Screening
  • History within past 6 months of alcohol abuse or illicit drug abuse
  • Unable, even with caregiver assistance, to comply with study procedures in opinion of investigator
  • Myocardial infarction within the 12 months prior to Screening
  • Hypothyroidism, vitamin B12 or folic acid deficiency
  • Known systemic infection (HBV, HCV, HIV, TB)
  • 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).

Treatment and study plan

Donepezil

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.

Other names: Aricept

AZD3480

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.

Other names: TC-1734

Primary outcomes

  1. Change from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)

    Time frame: 52 weeks

  2. 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.

  3. 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.

Secondary outcomes

  1. Change from baseline in the Neuropsychiatric Inventory (NPI)

    Time frame: 52 Weeks

  2. Change from baseline in the Mini-Mental State Examination (MMSE)

    Time frame: 52 Weeks

  3. Change from baseline in the Alzheimer's Disease Related Quality of Life (ADRQL)

    Time frame: 52 Weeks

Sponsors and collaborators

Lead sponsor

Targacept Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2011
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.