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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01019421




Registration number
NCT01019421
Ethics application status
Date submitted
24/11/2009
Date registered
25/11/2009
Date last updated
6/01/2012

Titles & IDs
Public title
Lu AE58054 Added to Donepezil for the Treatment for Moderate Alzheimer's Disease
Scientific title
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Moderate Alzheimer's Disease Treated With Donepezil
Secondary ID [1] 0 0
EudraCT 2009-011845-24
Secondary ID [2] 0 0
12936A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lu AE58054
Treatment: Drugs - Placebo

Experimental: Lu AE58054 -

Placebo Comparator: Placebo -


Treatment: Drugs: Lu AE58054
Add-on treatment to donepezil

Treatment: Drugs: Placebo
Add-on treatment to donepezil
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in cognition after 24 weeks
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics
Timepoint [1] 0 0
Week 24

Eligibility
Key inclusion criteria
- 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
278
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AU004 - East Gosford
Recruitment hospital [2] 0 0
AU002 - Heidelberg West
Recruitment hospital [3] 0 0
AU005 - Kew
Recruitment hospital [4] 0 0
AU001 - Nedlands
Recruitment hospital [5] 0 0
AU003 - Woodville South
Recruitment postcode(s) [1] 0 0
- East Gosford
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [3] 0 0
3101 - Kew
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Burlington
Country [3] 0 0
Canada
State/province [3] 0 0
Calgary
Country [4] 0 0
Canada
State/province [4] 0 0
Gatineau
Country [5] 0 0
Canada
State/province [5] 0 0
Kamloops
Country [6] 0 0
Canada
State/province [6] 0 0
Kingston
Country [7] 0 0
Canada
State/province [7] 0 0
Penticton
Country [8] 0 0
Canada
State/province [8] 0 0
Sherbrooke
Country [9] 0 0
Canada
State/province [9] 0 0
Toronto
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Kladno
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Kutna Hora
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Litomerice
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Praha 8
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Praha
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Rychnov nad Kneznou
Country [16] 0 0
Germany
State/province [16] 0 0
Ellwangen
Country [17] 0 0
Germany
State/province [17] 0 0
Erbach
Country [18] 0 0
Germany
State/province [18] 0 0
Frankfurt am Main
Country [19] 0 0
Germany
State/province [19] 0 0
Gunzburg
Country [20] 0 0
Germany
State/province [20] 0 0
Homburg
Country [21] 0 0
Germany
State/province [21] 0 0
Leipzig
Country [22] 0 0
Germany
State/province [22] 0 0
Munich
Country [23] 0 0
Germany
State/province [23] 0 0
Unterhaching
Country [24] 0 0
Italy
State/province [24] 0 0
Brescia
Country [25] 0 0
Italy
State/province [25] 0 0
Firenze
Country [26] 0 0
Italy
State/province [26] 0 0
Genova
Country [27] 0 0
Italy
State/province [27] 0 0
Lamezia Terme
Country [28] 0 0
Italy
State/province [28] 0 0
Milano
Country [29] 0 0
Italy
State/province [29] 0 0
Roma
Country [30] 0 0
Poland
State/province [30] 0 0
Bydgoszcz
Country [31] 0 0
Poland
State/province [31] 0 0
Krakow
Country [32] 0 0
Poland
State/province [32] 0 0
Lublin
Country [33] 0 0
Poland
State/province [33] 0 0
Sopot
Country [34] 0 0
Poland
State/province [34] 0 0
Szczecin
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Poland
State/province [36] 0 0
Warszaw
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Elche
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Majadahonda
Country [41] 0 0
Spain
State/province [41] 0 0
Terrassa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
H. Lundbeck A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01019421
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
[email protected]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01019421