Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease

Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease

The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.

The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of cognitive and behavioral symptoms in patients with Alzheimer's disease.

Inclusion Criteria:

• Informed consent obtained from the patient and legally acceptable representative, if required
• Informed consent obtained from the caregiver
• Males and and females between 55-90 years
• Diagnosis of probable Alzheimer's disease, history of progressive cognitive deterioration
• Brain imaging consistent with Alzheimer's disease
• Mini-mental state examination score 12-21
• Treated with donepezil, rivastigmine or galantamine
• At least mild level of behavioral symptoms

Exclusion Criteria:

• Other types of dementias
• Modified Hachinski Ischemia Score > 4
• Use of memantine, antipsychotics, anticholinergic medication and benzodiazepines (at a max of 3 nights/week) within 2 months
• Changes in antidepressant dosing within 2 months
• Use of other psychotropic agents
• Myocardial infarction within the past 2 years
• Malignancy within the past 5 years
• Suicidal ideation, risk of suicide
• History of alcoholism or drug abuse within 5 years
• Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness
• Specific findings in brain imaging
• Abnormal findings in heart rate, blood pressure, ECG, laboratory tests, physical examination; orthostatic hypotension
• Blood donation or participation in a drug study within 60 days
• Previous AD immunotherapy treatment
• Patient cannot complete the computerised cognitive training
• Patients who reside in a skilled nursing facility
• Patients who are not able to swallow capsules