Randomised, double-blind, parallel-group, placebocontrolled,fixed-dose study of Lu AE58054 in patients with moderate Alzheimers Disease treated with donepezil - ND
- Conditions
- Moderate Alzheimer DiseaseMedDRA version: 9.1Level: HLTClassification code 10001897
- Registration Number
- EUCTR2009-011845-24-IT
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
1. 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. 2. The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study. 3. The patient (or if applicable the LAR and if different from the responsible caregiver) and the responsible caregiver have signed the Informed Consent Form. 4. The patient has probable AD consistent with NINCDS-ADRDA criteria. 5. The patient is a man or woman, aged at least 50 years. 6. The patient is ambulatory or ambulatory aided (i.e., walker or cane). 7. The patient, if female, must have had her last natural menstruation at least 24 months prior to baseline or is surgically sterile. 8. The patient and the caregiver are, in the investigators judgement, proficient in the language in which the psychometric tests will be completed. 9. The patients sight and hearing (hearing aid permissible) are, in the investigators judgement, sufficient for compliance with the study procedures. 10. The patient has a MMSE score at screening and baseline of at least 12 and no greater than 19. 11. The patient has had a CT or a MRI within the last 6 months with results consistent with the diagnosis of probable AD. 12. The patient has been treated daily with donepezil for at least 4 months prior to the screening visit. The dose has been stable at 10 mg/day for the last 3 months prior to screening. 13. The patient has a physical examination, laboratory evaluations and ECG results from the screening and baseline visit that are normal, or abnormal findings are, in the investigators judgement, not to be judged as clinically significant. 14. The patient has a body mass index (BMI) of 18.5 kg/m2 or above.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.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, frontotemporal dementia, Parkinsons disease, Huntingtons disease, major cortical stroke, major head trauma and, primary or secondary cerebral neoplasia. 2.The patient has a history of seizures, with the exception of febrile seizures in childhood. 3.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. 4.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 Recherche` et l`Enseignement en Neurosciences (NINDS-AIREN) criteria for vascular dementia. 5.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. 6.The patient has evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease or metabolic disturbance (patients with controlled diabetes, or patients with controlled hypertension, or right bundle branch block, complete or partial, may be included in the study).As specified in the donepezil SPC special precaution is needed for patients with asthma, obstructive pulmonary disease, bradycardia and patients with difficulty in passing urine. 7.The patient has a recent (within 3 months of screening), or currently untreated, history of B12, thyroid stimulating hormone (TSH) or folate deficiency that is considered clinically significant (patients with thyroid disease may be included in the study, provided they are stable and euthyroid). 8.The patient has clinically significant abnormal vital signs. 9.The patient has one or more laboratory values outside the normal range, based on the blood or urine samples, which are, in the investigators judgement, considered to be clinically significant. 10.The patient has a clinically significant abnormal ECG. 11.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). 12.The patient has/has had a disorder related to alcohol or drug abuse or dependence (other than related to nicotine) as defined in DSM-IV-TR, within 5 years prior to screening. 13.The patient has a history of severe drug allergy (anaphylactic shock or drug-induced hypersensitivity syndrome), multiple allergies or known hypersensitivity to 5-HT6 receptor antagonists. 14.The patient used/uses disallowed recent or concomitant medication (specified in Appendix II), or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study. 15.The patient has been treated with a depot neuroleptic within 6 months of the screening visit. 16.The patients donepezil therapy is
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method