Clinical trial NCT01324518: Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease
Official title: Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 3 months
measure: Quality of Episodic Memory
timeFrame: 3 months
measure: Quality of Working Memory
timeFrame: 3 months
measure: Quality of Memory
timeFrame: 3 months
measure: Speed of Memory
timeFrame: 3 months
measure: Power of Attention
timeFrame: 3 months
measure: Continuity of Attention
timeFrame: 3 months
Secondary outcomes:
measure: NPI Total Score
timeFrame: 3 months
measure: Caregiver Distress Score
timeFrame: 3 months
measure: Pharmacokinetics of ORM-12741
timeFrame: 3 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Clinical Research Services Turku (CRST)
Study officials:
affiliation: Clinical Research services Turku (CRST)
name: Juha Rinne, Prof
role: PRINCIPAL_INVESTIGATOR
References: