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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: ORM-12741; Drug: ORM-12741; Drug: Placebo for ORM-12741

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20520
    • Clinical Research Services Turku (CRST)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo for ORM-12741; Placebo twice a day
Experimental: Low dose of ORM-12741	Drug: ORM-12741; 60mg twice a day; Drug: ORM-12741; 200mg twice a day
Experimental: High dose of ORM-12741	Drug: ORM-12741; 60mg twice a day; Drug: ORM-12741; 200mg twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Adverse events from start of ORM-12741 treatment until end of study visit.	3 months
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Pharmacokinetics of ORM-12741	ORM-12741 plasma trough concentrations at week 12.	3 months

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Investigators: Principal Investigator: Juha Rinne, Prof, Clinical Research Services Turku (CRST)

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 25, 2011
• First Posted (Estimate): March 29, 2011

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 3098006