Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease
NCT ID: NCT01324518
Last Updated: 2021-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2011-04-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose of ORM-12741
ORM-12741
60mg twice a day
High dose of ORM-12741
ORM-12741
200mg twice a day
Placebo
Placebo for ORM-12741
Placebo twice a day
Interventions
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ORM-12741
60mg twice a day
ORM-12741
200mg twice a day
Placebo for ORM-12741
Placebo twice a day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
90 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Juha Rinne, Prof
Role: PRINCIPAL_INVESTIGATOR
Clinical Research services Turku (CRST)
Locations
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Clinical Research Services Turku (CRST)
Turku, , Finland
Countries
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Related Links
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AAN 65th ANNUAL MEETING ABSTRACT
Other Identifiers
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3098006
Identifier Type: -
Identifier Source: org_study_id
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