Clinical trial NCT01019421 (phase 2, status: completed)
Conditions: alzheimer's disease
ICD codes: G30.8, G30.9, G30.0, G30.1
Drugs: lu ae58054, placebo
SMILES: FC(F)C(F)(F)COC1=CC=CC(CNCCC2=CNC3=CC(F)=CC=C23)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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.

        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.