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The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose of ORM-12741 | Experimental |
| |
| High dose of ORM-12741 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORM-12741 | Drug | 60mg twice a day |
| |
| ORM-12741 |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juha Rinne, Prof | Clinical Research services Turku (CRST) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Services Turku (CRST) | Turku | 20520 | Finland |
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| Label | URL |
|---|---|
| AAN 65th ANNUAL MEETING ABSTRACT | View source |
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A total of 132 subjects were screened and 100 were randomized to 3 treatment groups. 30 patients were excluded prior randomization due to inclusion/exclusion criteria, 2 due to personal reasons.
This study was conducted in 4 countries (18 centres): Finland, Poland, Romania and Spain. Of these, 1 centre screened but did not randomise any subjects. Study period was 27 Apr 2011-21 Sep 2012 (first subject first visit to last subject last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose of ORM-12741 | ORM-12741: 60mg twice a day |
| FG001 | High Dose of ORM-12741 | ORM-12741: 200mg twice a day |
| FG002 | Placebo | Placebo for ORM-12741: Placebo twice a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose of ORM-12741 | ORM-12741: 60mg twice a day |
| BG001 | High Dose of ORM-12741 | ORM-12741: 200mg twice a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Adverse events from start of ORM-12741 treatment until end of study visit. | Posted | Count of Participants | Participants | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose of ORM-12741 | ORM-12741: 60mg twice a day | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholestasis | Hepatobiliary disorders | Non-systematic Assessment | Cholestatic syndrome |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Director | Orion Global Clinical Operations | jutta.hanninen@orionpharma.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000588919 | ORM-12741 |
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| Drug |
200mg twice a day |
|
| Placebo for ORM-12741 | Drug | Placebo twice a day |
|
| 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 |
| 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 |
| BG002 |
| Placebo |
Placebo for ORM-12741: Placebo twice a day |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | per protocol population | Posted | Mean | Standard Deviation | Index score | 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. | per protocol population | Posted | Mean | Standard Deviation | Index score | 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. | per protocol population | Posted | Mean | Standard Deviation | Index score | 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. | per protocol population | Posted | Mean | Standard Deviation | msec | 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. | per protocol population | Posted | Mean | Standard Deviation | msec | 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. | per protocol population | Posted | Mean | Standard Deviation | Index score | 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. | per protocol population | Posted | Mean | Standard Deviation | score on a scale | 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. | per protocol population | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Pharmacokinetics of ORM-12741 | ORM-12741 plasma trough concentrations at week 12. | M-ITT population | Posted | Mean | Standard Deviation | ng/ml | 3 months |
|
|
|
| 33 |
| 0 |
| 33 |
| 8 |
| 33 |
| EG001 | High Dose of ORM-12741 | ORM-12741: 200mg twice a day | 0 | 33 | 1 | 33 | 14 | 33 |
| EG002 | Placebo | Placebo for ORM-12741: Placebo twice a day | 0 | 34 | 0 | 34 | 16 | 34 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Irritability | General disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |