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

NCT01466088 | Completed Phase 2

• 1 other identifier: TC-1734-226-CRD-006
• Study Type: interventional
• Target: 386
• Locations: 5 countries
• Sites: 33

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; AD; Dementia

Outcome Measures

Primary Outcomes (3)

• 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-(+)]

  The CIBIC-(+) is a co-primary endpoint with the ADAS-Cog in the United States.

  52 Weeks

• Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

  The ADCS-ADL is the co-primary endpoint with the ADAS-Cog in Europe.

  52 Weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

AZD3480

EXPERIMENTAL

Drug: AZD3480

Donepezil

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Aricept

Donepezil

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.

Also known as: TC-1734

AZD3480

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Targacept Inc.: lead

Study Sites (33)

Banner Alzheimer Institute

Phoenix, Arizona, 85006, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Policlinic

Choceň, Czechia

Location

BRAIN-SOULTHERAPY s.r.o.

Kladno, Czechia

Location

Bialbi.s.r.o. Psychiatrické oddělení

Litoměřice, Czechia

Location

Psychiatricka Ambulance

Olomouc, Czechia

Location

Vojenska Nemocnice Psychiatricke oddeleni

Olomouc, Czechia

Location

Clintrial

Prague, Czechia

Location

PRAGTIS s.r.o.

Prague, Czechia

Location

Psychosocialni centrum

Přerov, Czechia

Location

Crucea Alba - Dr. Oros si Asociatii - Societate Civila Medicala

Oradea, 410163, Romania

Location

Spitalul de Psihiatrie Sibiu

Sibiu, 550012, Romania

Location

Spitalul Clinic Judetean de Urgenta SIBIU

Sibiu, 550166, Romania

Location

Spitalul Clinic Judetean de Urgenta, Clinica Psihiatrie

Timișoara, 300128, Romania

Location

Spitalul Clinic Judetean de Urgenta, Clinica Neurologie 2

Timișoara, 300736, Romania

Location

Neurologicka Ambulancia, s.r.o.

Banská Bystrica, Slovakia

Location

Univerzitna nemocnica Bratislava, Geronto-psychiatrické oddelenie

Bratislava, Slovakia

Location

KONZILIUM s.r.o.

Dubnica nad Váhom, Slovakia

Location

Neurologická ambulancia

Krompachy, Slovakia

Location

Dnipropetrovsk Regional Clinical Hospital

Dnipropetrovsk, 49005, Ukraine

Location

Donetsk National Medical University of M. Gorky

Donetsk, 83003, Ukraine

Location

Donetsk Regional Clinical Psychiatric Hospital

Donetsk, 83008, Ukraine

Location

Crimean Republican Institution Psychoneurological Dispensary

Kerch, 98310, Ukraine

Location

Central Clinical Hospital Ukrzaliznytsi

Kharkiv, 61103, Ukraine

Location

Department of Age Physiology and Pathology of Nervous System; Institute of Gerontology NAMS

Kyiv, 04114, Ukraine

Location

Lugansk Regional Clinical Psychoneurological Hospital

Luhansk, 91045, Ukraine

Location

Lviv National Medical University named after Galytskyy

Lviv, 79010, Ukraine

Location

Lviv Regional Clinical Psychiatric Hospital

Lviv, 79021, Ukraine

Location

Odessa Regional Psychoneurology Dispensary

Odesa, 65014, Ukraine

Location

Odessa Regional Psychiatric Hospital # 2

Oleksandrivka, 67513, Ukraine

Location

Ukrainian Medical Stomatological Academy

Poltava, 36006, Ukraine

Location

Department #3 of the Kherson Regional Psychiatric Hospital

Stepanovka, 73488, Ukraine

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Donepezil; ispronicline

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Pierre Tariot, MD

  Banner Alzheimer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 7, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2014-07

Locations

SL (4); RO (5); UA (13); CZ (8); US (3)