AzTrials
AzTrials

Alzheimer's DiseasePhase 2NCT01019421

Lu AE58054 Added to Donepezil for the Treatment for Moderate Alzheimer's Disease

A Phase 2 study testing Lu AE58054 in people with Alzheimer's Disease, run by H. Lundbeck A/S at 51 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to accept or reject the hypothesis that Lu AE58054 improves cognition and functional outcomes in patients with moderate Alzheimer's Disease, already in treatment with donepezil. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Lu AE58054
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
278 participants
Where
51 sitesin 7 countries
Study dates
Dec 2009to Dec 2011
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient (or if applicable the legally acceptable representative (LAR) and if different from the responsible caregiver) and the responsible caregiver are able to read and understand the Informed Consent Form.
  • The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study.
  • The patient (or if applicable the LAR and if different from the responsible caregiver) and the responsible caregiver have signed the Informed Consent Form.
  • The patient has probable AD consistent with NINCDS-ADRDA criteria.
  • The patient is a man or woman, aged at least 50 years.
  • The patient has been treated with donepezil on a stable dose for at least 3 months prior to screening.

Who cannot join

  • The patient has evidence of any clinically significant neurodegenerative disease or other serious neurological disorders other than AD including but not limited to Lewy body dementia, fronto-temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, major head trauma and, primary or secondary cerebral neoplasia.
  • The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD including amnestic disorders, major depressive disorder, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, psychosis, panic, post traumatic stress disorder or/and cognitive disorder not otherwise specified.
  • The patient has clinical and radiological findings that fulfil the standards of the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria for vascular dementia.
  • The patient has CT or MRI evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection or any clinically significant central nervous system disease other than AD.
  • The patient has clinically significant abnormal vital signs.
  • The patient has one or more laboratory values outside the normal range, based on the blood or urine samples, which are, in the investigator's judgement, considered to be clinically significant.
Show all 14Show fewer
  • The patient has a clinically significant abnormal ECG.
  • The patient has an oncological diagnosis (haematological or solid tumour) that is currently being treated, or for which there has been treatment within 5 years preceding screening, or for which there is still evidence of active disease (patients with local dermatological tumours such as basal or squamous cell carcinoma may be included).
  • The patient's donepezil therapy is likely to be interrupted or discontinued during the study.
  • The patient has a disease or takes medication that, in the investigator's judgement, could interfere with the assessments of safety, tolerability, or efficacy.
  • The patient is, in the investigator's judgement, unlikely to comply with the clinical study protocol or is unsuitable for any reason.
  • The patient is a member of the site personnel or their immediate families.
  • The patient is treated against his/her will (for example, by court order).
  • The patient or patient caregiver is unwilling or unable to abide by the visit schedule and other requirements of the study.

Trial locations and contacts

51 sites in 7 countries.

51 sites in 7 countries

Canada9 sites

  • CA007

    Burlington, L7M 4Y1

  • CA006

    Calgary, T2N 4Z6

  • CA008

    Gatineau, JA 1K7

  • CA011

    Kamloops, V2C 1K7

  • CA002

    Kingston, K7L 5G2

  • CA010

    Penticton, V2A 5C8

  • CA004

    Sherbrooke, J1J 3H5

  • CA005

    Toronto, Ontario

  • CA001

    Toronto, M3B 2S7

Other trials in Canada

Czechia8 sites

  • CZ001

    Kladno, 27301

  • CZ002

    Kutná Hora, 28401

  • CZ007

    Litoměřice, 41201

  • CZ005

    Prague, 1000

  • CZ008

    Prague, 15800

  • CZ006

    Prague, 16000

  • CZ004

    Prague, 18000

  • CZ003

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Germany8 sites

  • DE004

    Ellwangen, 73479

  • DE003

    Erbach im Odenwald, 64711

  • DE005

    Frankfurt am Main, 60528

  • DE002

    Günzburg, 89312

  • DE001

    Homburg, 66421

  • DE006

    Leipzig, 4107

  • DE009

    Munich, 81366

  • DE007

    Unterhaching, 82008

Other trials in Germany

Poland8 sites

  • PL002

    Bydgoszcz, 87-793

  • PL001

    Krakow, 30-321

  • PL007

    Lublin, 20-950

  • PL003

    Sopot, 81-824

  • PL009

    Szczecin, 70-215

  • PL004

    Warsaw, 01-211

  • PL005

    Warsaw, 01-231

  • PL008

    Warsaw, 02-765

Other trials in Poland

Italy7 sites

  • IT001

    Brescia, 25123

  • IT005

    Brescia, 25127

  • IT008

    Florence, 50141

  • IT003

    Genova

  • IT004

    Lamezia Terme, 88046

  • IT007

    Milan, 20122

  • IT002

    Roma, 185

Other trials in Italy

Spain6 sites

  • ES002

    Barcelona, 8014

  • ES003

    Elche, 3203

  • ES004

    Madrid, 28031

  • ES005

    Madrid, 28040

  • ES006

    Majadahonda, 28222

  • ES001

    Terrassa, 8221

Other trials in Spain

Australia5 sites

  • AU004

    East Gosford

  • AU002

    Heidelberg West, 3081

  • AU005

    Kew, 3101

  • AU001

    Nedlands, 6009

  • AU003

    Woodville South, 5011

Other trials in Australia

About this study

Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Moderate Alzheimer's Disease Treated With Donepezil

The purpose of this study is to accept or reject the hypothesis that Lu AE58054 improves cognition and functional outcomes in patients with moderate Alzheimer's Disease, already in treatment with donepezil.

Read the detailed description

Multi-centre, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE58054 as add-on to donepezil. The patient has probable Alzheimer's Disease consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.

Being tested
Lu AE58054, Placebo
Keywords
Cognition
Medical subject headings
Alzheimer Disease

What participants receive

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

  • Lu AE58054Drug

    Add-on treatment to donepezil

  • PlaceboDrug

    Add-on treatment to donepezil

Study groups in NCT01019421
Study groupRoleWhat they receive
Lu AE58054ExperimentalNot described
Receives: Drug: Lu AE58054
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change in cognition after 24 weeks

    Measured: Week 24

Secondary outcomes (1)

  1. Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics

    Measured: Week 24

Timeline

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

  1. First posted25 Nov 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionDec 2011

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
Double blind
Who is masked
Participant, Investigator
Enrolment
278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01019421
Sponsor's protocol ID
12936A
Other IDs
EudraCT 2009-011845-24
Status last verified
Jan 2012
First submitted
24 Nov 2009
Last updated
6 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • Wilkinson D, Windfeld K, Colding-Jorgensen E. Safety and efficacy of idalopirdine, a 5-HT6 receptor antagonist, in patients with moderate Alzheimer's disease (LADDER): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2014 Nov;13(11):1092-1099. doi: 10.1016/S1474-4422(14)70198-X. Epub 2014 Oct 5.

    PubMed 25297016

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lu AE58054 in people with Alzheimer's Disease, run by H. Lundbeck A/S at 51 sites in 7 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 6 inclusion and 14 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 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Canada, Czechia, Germany, Poland, Italy and 2 more countries. 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. Some participants in this study may receive a placebo. 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 in cognition after 24 weeks (time frame: Week 24). 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 NCT01019421, which also lists 1 linked publication.

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 6 Jan 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in