Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Targacept Inc.
ClinicalTrials.gov Identifier:
NCT01466088
First received: November 2, 2011
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: Donepezil
Drug: AZD3480
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Targacept Inc.:

Primary Outcome Measures:
  • Change from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Clinician Interview-Based Impression of Change plus carer interview [CIBIC-(+)] [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    The CIBIC-(+) is a co-primary endpoint with the ADAS-Cog in the United States.

  • Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    The ADCS-ADL is the co-primary endpoint with the ADAS-Cog in Europe.


Secondary Outcome Measures:
  • Change from baseline in the Neuropsychiatric Inventory (NPI) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Mini-Mental State Examination (MMSE) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Alzheimer's Disease Related Quality of Life (ADRQL) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Enrollment: 386
Study Start Date: October 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466088

Locations
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
Policlinic
Chocen, Czech Republic
BRAIN-SOULTHERAPY s.r.o.
Kladno, Czech Republic
Bialbi.s.r.o. Psychiatrické oddělení
Litoměřice, Czech Republic
Psychiatricka Ambulance
Olomouc, Czech Republic
Vojenska Nemocnice Psychiatricke oddeleni
Olomouc, Czech Republic
PRAGTIS s.r.o.
Praha, Czech Republic
Clintrial
Praha, Czech Republic
Psychosocialni centrum
Prerov, Czech Republic
Romania
Crucea Alba - Dr. Oros si Asociatii - Societate Civila Medicala
Oradea, Romania, 410163
Spitalul Clinic Judetean de Urgenta SIBIU
Sibiu, Romania, 550166
Spitalul de Psihiatrie Sibiu
Sibiu, Romania, 550012
Spitalul Clinic Judetean de Urgenta, Clinica Psihiatrie
Timisoara, Romania, 300128
Spitalul Clinic Judetean de Urgenta, Clinica Neurologie 2
Timisoara, Romania, 300736
Slovakia
Neurologicka Ambulancia, s.r.o.
Banska Bystrica, Slovakia
Univerzitna nemocnica Bratislava, Geronto-psychiatrické oddelenie
Bratislava, Slovakia
KONZILIUM s.r.o.
Dubnica nad Váhom, Slovakia
Neurologická ambulancia
Krompachy, Slovakia
Ukraine
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.
Investigators
Principal Investigator: Pierre Tariot, MD Banner Alzheimer Institute
  More Information

No publications provided

Responsible Party: Targacept Inc.
ClinicalTrials.gov Identifier: NCT01466088     History of Changes
Other Study ID Numbers: TC-1734-226-CRD-006
Study First Received: November 2, 2011
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Ukraine: Ministry of Health

Keywords provided by Targacept Inc.:
Alzheimer's Disease
AD
Dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014