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Alzheimer's DiseasePhase 2NCT01466088

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

A Phase 2 study testing Donepezil and AZD3480 in people with Alzheimer's Disease, run by Targacept Inc. at 33 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Donepezil and AZD3480
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
386 participants
Where
33 sitesin 5 countries
Study dates
Oct 2011to May 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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).

Trial locations and contacts

33 sites in 5 countries.

33 sites in 5 countries

Ukraine13 sites

  • Dnipropetrovsk Regional Clinical Hospital

    Dnipropetrovsk, 49005

  • Donetsk National Medical University of M. Gorky

    Donetsk, 83003

  • Donetsk Regional Clinical Psychiatric Hospital

    Donetsk, 83008

  • Crimean Republican Institution Psychoneurological Dispensary

    Kerch, 98310

  • Central Clinical Hospital Ukrzaliznytsi

    Kharkiv, 61103

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

    Kyiv, 04114

  • Lugansk Regional Clinical Psychoneurological Hospital

    Luhansk, 91045

  • Lviv National Medical University named after Galytskyy

    Lviv, 79010

  • Lviv Regional Clinical Psychiatric Hospital

    Lviv, 79021

  • Odessa Regional Psychoneurology Dispensary

    Odesa, 65014

  • Odessa Regional Psychiatric Hospital # 2

    Oleksandrivka, 67513

  • Ukrainian Medical Stomatological Academy

    Poltava, 36006

  • Department #3 of the Kherson Regional Psychiatric Hospital

    Stepanovka, 73488

Other trials in Ukraine

Czechia8 sites

  • Policlinic

    Choceň

  • BRAIN-SOULTHERAPY s.r.o.

    Kladno

  • Bialbi.s.r.o. Psychiatrické oddělení

    Litoměřice

  • Psychiatricka Ambulance

    Olomouc

  • Vojenska Nemocnice Psychiatricke oddeleni

    Olomouc

  • Clintrial

    Prague

  • PRAGTIS s.r.o.

    Prague

  • Psychosocialni centrum

    Přerov

Other trials in Czechia

Romania5 sites

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

    Oradea, 410163

  • Spitalul de Psihiatrie Sibiu

    Sibiu, 550012

  • Spitalul Clinic Judetean de Urgenta SIBIU

    Sibiu, 550166

  • Spitalul Clinic Judetean de Urgenta, Clinica Psihiatrie

    Timișoara, 300128

  • Spitalul Clinic Judetean de Urgenta, Clinica Neurologie 2

    Timișoara, 300736

Other trials in Romania

Slovakia4 sites

  • Neurologicka Ambulancia, s.r.o.

    Banská Bystrica

  • Univerzitna nemocnica Bratislava, Geronto-psychiatrické oddelenie

    Bratislava

  • KONZILIUM s.r.o.

    Dubnica nad Váhom

  • Neurologická ambulancia

    Krompachy

Other trials in Slovakia

United States3 sites

  • Meridien Research

    Brooksville, Florida, 34601

  • MD Clinical

    Hallandale, Florida, 33009

  • Banner Alzheimer Institute

    Phoenix, Arizona, 85006

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Donepezil, AZD3480
Keywords
Alzheimer's Disease, AD, Dementia
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DonepezilDrug

    Also called Aricept

    Subjects taking donepezil will take 1-2 capsules of 5 mg donepezil and a placebo for AZD3480 (to maintain blind) orally once a day.

  • AZD3480Drug

    Also called TC-1734

    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.

Study groups in NCT01466088
Study groupRoleWhat they receive
AZD3480ExperimentalNot described
Receives: Drug: AZD3480
DonepezilActive comparatorDonepezil will be administered at 5 mg daily for 4 weeks and escalated to 10 mg daily for the remainder of the study.
Receives: Drug: Donepezil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)

    Measured: 52 weeks

  2. 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.

    Measured: 52 Weeks

  3. 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.

    Measured: 52 Weeks

Secondary outcomes (3)

  1. Change from baseline in the Neuropsychiatric Inventory (NPI)

    Measured: 52 Weeks

  2. Change from baseline in the Mini-Mental State Examination (MMSE)

    Measured: 52 Weeks

  3. Change from baseline in the Alzheimer's Disease Related Quality of Life (ADRQL)

    Measured: 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01466088
Sponsor's protocol ID
TC-1734-226-CRD-006
Status last verified
Jul 2014
First submitted
2 Nov 2011
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donepezil and AZD3480 in people with Alzheimer's Disease, run by Targacept Inc. at 33 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Ukraine, Czechia, Romania, Slovakia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) (time frame: 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01466088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.

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