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

Alzheimer's Disease Clinical Trial

— ALPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324518
• Other study ID #: 3098006
• Status: Completed
• Phase: Phase 2
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: April 2021
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ORM-12741
60mg twice a day
• ORM-12741
200mg twice a day
• Placebo for ORM-12741
Placebo twice a day

Locations

Country	Name	City	State
Finland	Clinical Research Services Turku (CRST)	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Adverse events from start of ORM-12741 treatment until end of study visit.	3 months
Primary	Quality of Episodic Memory	The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Quality of Episodic Memory measures the capability of maintaining information in episodic memory and is assessed as the sum of sensitivity indices from 4 memory tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.	3 months
Primary	Quality of Working Memory	The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Quality of Working Memory measures the capability of maintaining information in working memory and is assessed as the sum of sensitivity indices from 2 memory tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.	3 months
Primary	Quality of Memory	The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Quality of Memory is a combination of outcome measures Quality of Working Memory & Quality of Episodic Memory. Values are calculated by a computer and higher scores mean better outcome.	3 months
Primary	Speed of Memory	The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Speed of Memory is assessed as the sum of speed measures from 2 memory tasks and 2 recognition tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.	3 months
Primary	Power of Attention	The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Power of attention measures speed and attention and is assessed from 3 attentional tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.	3 months
Primary	Continuity of Attention	The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.	3 months
Secondary	NPI Total Score	The total score of Neuropsychiatric Inventory (NPI) was assessed by a caregiver interview. 10 behavioral areas were included: Delusions, Hallucinations, Agitation/Aggression, Depression/Dysphoria, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability/Lability, and Aberrant Motor Behaviour. Higher scores mean worse outcome. Minimum value 0, maximum value 120.	3 months
Secondary	Caregiver Distress Score	Caregiver distress score generated by adding together the scores of individual NPI distress questions of Neuropsychiatric Inventory NPI. Higher scores mean worse outcome. Minimum value 0, maximum value 120.	3 months
Secondary	Pharmacokinetics of ORM-12741	ORM-12741 plasma trough concentrations at week 12.	3 months

External Links

•   A poster of the study results
•   AAN 65th ANNUAL MEETING ABSTRACT
•   An article of the study results