Clinical trial NCT01466088: Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
AD
Dementia
Lead sponsor: Targacept Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-06
Enrollment: 386
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Change from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
timeFrame: 52 weeks
measure: Change from baseline in the Clinician Interview-Based Impression of Change plus carer interview [CIBIC-(+)]
timeFrame: 52 Weeks
measure: Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
timeFrame: 52 Weeks
Secondary outcomes:
measure: Change from baseline in the Neuropsychiatric Inventory (NPI)
timeFrame: 52 Weeks
measure: Change from baseline in the Mini-Mental State Examination (MMSE)
timeFrame: 52 Weeks
measure: Change from baseline in the Alzheimer's Disease Related Quality of Life (ADRQL)
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer Institute
state: Arizona
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Chocen
country: Czech Republic
facility: Policlinic
city: Kladno
country: Czech Republic
facility: BRAIN-SOULTHERAPY s.r.o.
city: Litoměřice
country: Czech Republic
facility: Bialbi.s.r.o. Psychiatrické oddělení
city: Olomouc
country: Czech Republic
facility: Psychiatricka Ambulance
city: Olomouc
country: Czech Republic
facility: Vojenska Nemocnice Psychiatricke oddeleni
city: Praha
country: Czech Republic
facility: Clintrial
city: Praha
country: Czech Republic
facility: PRAGTIS s.r.o.
city: Prerov
country: Czech Republic
facility: Psychosocialni centrum
city: Oradea
country: Romania
facility: Crucea Alba - Dr. Oros si Asociatii - Societate Civila Medicala
city: Sibiu
country: Romania
facility: Spitalul de Psihiatrie Sibiu
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta SIBIU
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta, Clinica Psihiatrie
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta, Clinica Neurologie 2
city: Banska Bystrica
country: Slovakia
facility: Neurologicka Ambulancia, s.r.o.
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Geronto-psychiatrické oddelenie
city: Dubnica nad Váhom
country: Slovakia
facility: KONZILIUM s.r.o.
city: Krompachy
country: Slovakia
facility: Neurologická ambulancia
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Regional Clinical Hospital
city: Donetsk
country: Ukraine
facility: Donetsk National Medical University of M. Gorky
city: Donetsk
country: Ukraine
facility: Donetsk Regional Clinical Psychiatric Hospital
city: Kerch
country: Ukraine
facility: Crimean Republican Institution Psychoneurological Dispensary
city: Kharkiv
country: Ukraine
facility: Central Clinical Hospital Ukrzaliznytsi
city: Kyiv
country: Ukraine
facility: Department of Age Physiology and Pathology of Nervous System; Institute of Gerontology NAMS
city: Lugansk
country: Ukraine
facility: Lugansk Regional Clinical Psychoneurological Hospital
city: Lviv
country: Ukraine
facility: Lviv National Medical University named after Galytskyy
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Psychiatric Hospital
city: Odessa
country: Ukraine
facility: Odessa Regional Psychoneurology Dispensary
city: Oleksandrivka
country: Ukraine
facility: Odessa Regional Psychiatric Hospital # 2
city: Poltava
country: Ukraine
facility: Ukrainian Medical Stomatological Academy
city: Stepanovka
country: Ukraine
facility: Department #3 of the Kherson Regional Psychiatric Hospital
Study officials:
affiliation: Banner Alzheimer Institute
name: Pierre Tariot, MD
role: PRINCIPAL_INVESTIGATOR
References: