Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)
- Registration Number
- NCT01466088
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 386
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZD3480 AZD3480 - Donepezil Donepezil Donepezil will be administered at 5 mg daily for 4 weeks and escalated to 10 mg daily for the remainder of the study.
- Primary Outcome Measures
Name Time Method Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) 52 Weeks The ADCS-ADL is the co-primary endpoint with the ADAS-Cog in Europe.
Change from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) 52 weeks Change from baseline in the Clinician Interview-Based Impression of Change plus carer interview [CIBIC-(+)] 52 Weeks The CIBIC-(+) is a co-primary endpoint with the ADAS-Cog in the United States.
- Secondary Outcome Measures
Name Time Method Change from baseline in the Neuropsychiatric Inventory (NPI) 52 Weeks Change from baseline in the Mini-Mental State Examination (MMSE) 52 Weeks Change from baseline in the Alzheimer's Disease Related Quality of Life (ADRQL) 52 Weeks
Trial Locations
- Locations (33)
Odessa Regional Psychoneurology Dispensary
πΊπ¦Odessa, Ukraine
Dnipropetrovsk Regional Clinical Hospital
πΊπ¦Dnipropetrovsk, Ukraine
Central Clinical Hospital Ukrzaliznytsi
πΊπ¦Kharkiv, Ukraine
Odessa Regional Psychiatric Hospital # 2
πΊπ¦Oleksandrivka, Ukraine
Policlinic
π¨πΏChocen, Czech Republic
BRAIN-SOULTHERAPY s.r.o.
π¨πΏKladno, Czech Republic
MD Clinical
πΊπΈHallandale Beach, Florida, United States
Banner Alzheimer Institute
πΊπΈPhoenix, Arizona, United States
Psychiatricka Ambulance
π¨πΏOlomouc, Czech Republic
Meridien Research
πΊπΈBrooksville, Florida, United States
Bialbi.s.r.o. PsychiatrickΓ© oddΔlenΓ
π¨πΏLitomΔΕice, Czech Republic
Clintrial
π¨πΏPraha, Czech Republic
Vojenska Nemocnice Psychiatricke oddeleni
π¨πΏOlomouc, Czech Republic
Psychosocialni centrum
π¨πΏPrerov, Czech Republic
Crucea Alba - Dr. Oros si Asociatii - Societate Civila Medicala
π·π΄Oradea, Romania
Spitalul de Psihiatrie Sibiu
π·π΄Sibiu, Romania
Spitalul Clinic Judetean de Urgenta SIBIU
π·π΄Sibiu, Romania
Spitalul Clinic Judetean de Urgenta, Clinica Neurologie 2
π·π΄Timisoara, Romania
Neurologicka Ambulancia, s.r.o.
πΈπ°Banska Bystrica, Slovakia
Univerzitna nemocnica Bratislava, Geronto-psychiatrickΓ© oddelenie
πΈπ°Bratislava, Slovakia
KONZILIUM s.r.o.
πΈπ°Dubnica nad VΓ‘hom, Slovakia
NeurologickΓ‘ ambulancia
πΈπ°Krompachy, Slovakia
Donetsk National Medical University of M. Gorky
πΊπ¦Donetsk, Ukraine
Donetsk Regional Clinical Psychiatric Hospital
πΊπ¦Donetsk, Ukraine
Department of Age Physiology and Pathology of Nervous System; Institute of Gerontology NAMS
πΊπ¦Kyiv, Ukraine
Ukrainian Medical Stomatological Academy
πΊπ¦Poltava, Ukraine
PRAGTIS s.r.o.
π¨πΏPraha, Czech Republic
Spitalul Clinic Judetean de Urgenta, Clinica Psihiatrie
π·π΄Timisoara, Romania
Crimean Republican Institution Psychoneurological Dispensary
πΊπ¦Kerch, Ukraine
Lugansk Regional Clinical Psychoneurological Hospital
πΊπ¦Lugansk, Ukraine
Lviv National Medical University named after Galytskyy
πΊπ¦Lviv, Ukraine
Lviv Regional Clinical Psychiatric Hospital
πΊπ¦Lviv, Ukraine
Department #3 of the Kherson Regional Psychiatric Hospital
πΊπ¦Stepanovka, Ukraine