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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01466088
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : June 3, 2015
Information provided by (Responsible Party):
Targacept Inc.

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Donepezil Drug: AZD3480 Phase 2

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  (Clinical Trial)
Actual Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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 Name: 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 Name: Aricept

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01466088

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

Responsible Party: Targacept Inc. Identifier: NCT01466088     History of Changes
Other Study ID Numbers: TC-1734-226-CRD-006
First Posted: November 7, 2011    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: July 2014

Keywords provided by Targacept Inc.:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents