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

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
Study Start Date :	April 2011
Actual Primary Completion Date :	September 2012
Actual Study Completion Date :	October 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. Safety measures, i.e. assessing adverse events, vital signs, ECG,safety laboratory values [ Time Frame: 3 months ]
2. 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 :

1. Scores on Neuropsychiatric Inventory NPI assessment scale [ Time Frame: 3 months ]
2. Pharmacokinetics of ORM-12741, metabolites and AChE inhibitor [ Time Frame: 3 months ]
   Determination of ORM-12741, metabolites and acetylcholinesterase inhibitor concentrations in plasma
3. Scores on Cornell Scale for Depression in Dementia CSDD [ Time Frame: 3 months ]
4. Scores on Cognitive Failures Questionnaire CFQ [ Time Frame: 3 months ]
5. Scores on Clinical Global Impression of Change CGI-C [ Time Frame: 3 months ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

AAN 65th ANNUAL MEETING ABSTRACT 

Responsible Party:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT01324518 History of Changes
Other Study ID Numbers:	3098006
First Posted:	March 29, 2011
Last Update Posted:	October 21, 2014
Last Verified:	October 2014

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders