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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01324518
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ORM-12741 Drug: Placebo for ORM-12741 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease
Actual Study Start Date : April 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose of ORM-12741 Drug: ORM-12741
60mg twice a day
Experimental: High dose of ORM-12741 Drug: ORM-12741
200mg twice a day
Placebo Comparator: Placebo Drug: Placebo for ORM-12741
Placebo twice a day


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 3 months ]
    Adverse events from start of ORM-12741 treatment until end of study visit.

  2. Quality of Episodic Memory [ Time Frame: 3 months ]
    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. Quality of Working Memory [ Time Frame: 3 months ]
    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.

  4. Quality of Memory [ Time Frame: 3 months ]
    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.

  5. Speed of Memory [ Time Frame: 3 months ]
    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.

  6. Power of Attention [ Time Frame: 3 months ]
    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.

  7. Continuity of Attention [ Time Frame: 3 months ]
    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 :
  1. NPI Total Score [ Time Frame: 3 months ]
    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.

  2. Caregiver Distress Score [ Time Frame: 3 months ]
    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. Pharmacokinetics of ORM-12741 [ Time Frame: 3 months ]
    ORM-12741 plasma trough concentrations at week 12.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324518


Locations
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Finland
Clinical Research Services Turku (CRST)
Turku, Finland, 20520
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Principal Investigator: Juha Rinne, Prof Clinical Research services Turku (CRST)
More Information
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Additional Information:

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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01324518    
Other Study ID Numbers: 3098006
First Posted: March 29, 2011    Key Record Dates
Results First Posted: April 28, 2021
Last Update Posted: April 28, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders