Randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE58054 in patients with moderate Alzheimer's Disease treated with donepezil
- Conditions
- u AE58054 is under development by H.Lundbeck A/S for the treatment of Alzheimer's disease.MedDRA version: 13.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders
- Registration Number
- EUCTR2009-011845-24-DE
- 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 investigator’s judgement, proficient in the language in which the psychometric tests will be completed.
9. The patient’s sight and hearing (hearing aid permissible) are, in the investigator’s 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 normal physical examination at the screening and baseline visits and normal laboratory evaluations, urine tests and ECG results from the screening visit, or abnormal findings (except ALT, AST, ?GT, AP and bilirubin) that are not clinically significant, as judged by the investigator.
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, fronto-temporal dementia, Parkinson’s disease, Huntington’s 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, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post traumatic stress disorder or/and cognitive disorder not otherwise specified. (Note patients may be included if,...)
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 Recherché 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 an untreated B12 or folate deficiency that is considered clinically significant or has abnormal thyroid stimulating hormone (TSH) levels. ( Note, patients with a history of B12 or folate deficiency may be included in the study provided that they have been on a supplement therapy for at least 3 month and are stabel. 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 an ALT, AST, ?GT, AP or bilirubin value outside the normal range at
the screening visit.
10.The patient has a clinically significant abnormal ECG from the screening visit
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 Error! Reference source not found.), 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
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