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Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease (ALPO)
This study has been completed.
Sponsor:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01324518
First received: March 24, 2011
Last updated: October 20, 2014
Last verified: October 2014
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Purpose
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: ORM-12741 Drug: Placebo for ORM-12741 | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Orion Corporation, Orion Pharma:
Primary Outcome Measures:
- Safety measures, i.e. assessing adverse events, vital signs, ECG,safety laboratory values [ Time Frame: 3 months ]
- Efficacy measures on cognitive symptoms, i.e. CDR computerised cognitive test battery, COWAT and CFT [ Time Frame: 3 months ]Cognitive Drug Research computerised test battery, Controlled Oral Word Association test COWAT and Category Fluency Test CFT.
Secondary Outcome Measures:
- Scores on Neuropsychiatric Inventory NPI assessment scale [ Time Frame: 3 months ]
- Pharmacokinetics of ORM-12741, metabolites and AChE inhibitor [ Time Frame: 3 months ]Determination of ORM-12741, metabolites and acetylcholinesterase inhibitor concentrations in plasma
- Scores on Cornell Scale for Depression in Dementia CSDD [ Time Frame: 3 months ]
- Scores on Cognitive Failures Questionnaire CFQ [ Time Frame: 3 months ]
- Scores on Clinical Global Impression of Change CGI-C [ Time Frame: 3 months ]
| Enrollment: | 100 |
| Study Start Date: | April 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years (Adult, Senior) |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324518
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324518
Locations
| Finland | |
| Clinical Research Services Turku (CRST) | |
| Turku, Finland, 20520 | |
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
| Principal Investigator: | Juha Rinne, Prof | Clinical Research services Turku (CRST) |
More Information
Additional Information:
| Responsible Party: | Orion Corporation, Orion Pharma |
| ClinicalTrials.gov Identifier: | NCT01324518 History of Changes |
| Other Study ID Numbers: |
3098006 |
| Study First Received: | March 24, 2011 |
| Last Updated: | October 20, 2014 |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 21, 2017