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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
ORM-12741
ORM-12741
Placebo for ORM-12741
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Services Turku (CRST)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose of ORM-12741

High dose of ORM-12741

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
Adverse events from start of ORM-12741 treatment until end of study visit.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
Pharmacokinetics of ORM-12741
ORM-12741 plasma trough concentrations at week 12.

Full Information

First Posted
March 24, 2011
Last Updated
April 1, 2021
Sponsor
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01324518
Brief Title
Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease
Acronym
ALPO
Official Title
Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose of ORM-12741
Arm Type
Experimental
Arm Title
High dose of ORM-12741
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ORM-12741
Intervention Description
60mg twice a day
Intervention Type
Drug
Intervention Name(s)
ORM-12741
Intervention Description
200mg twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo for ORM-12741
Intervention Description
Placebo twice a day
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Adverse events from start of ORM-12741 treatment until end of study visit.
Time Frame
3 months
Title
Quality of Episodic Memory
Description
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.
Time Frame
3 months
Title
Quality of Working Memory
Description
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.
Time Frame
3 months
Title
Quality of Memory
Description
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.
Time Frame
3 months
Title
Speed of Memory
Description
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.
Time Frame
3 months
Title
Power of Attention
Description
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.
Time Frame
3 months
Title
Continuity of Attention
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
NPI Total Score
Description
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.
Time Frame
3 months
Title
Caregiver Distress Score
Description
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.
Time Frame
3 months
Title
Pharmacokinetics of ORM-12741
Description
ORM-12741 plasma trough concentrations at week 12.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juha Rinne, Prof
Organizational Affiliation
Clinical Research services Turku (CRST)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Services Turku (CRST)
City
Turku
ZIP/Postal Code
20520
Country
Finland

12. IPD Sharing Statement

Links:
URL
https://www.aan.com/PressRoom/Home/GetDigitalAsset/10708
Description
AAN 65th ANNUAL MEETING ABSTRACT

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

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