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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma

Criteria

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