Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Genetic and Rare Diseases Information Center resources: Familial Alzheimer 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 ] [ Designated as safety issue: Yes ]
Efficacy measures on cognitive symptoms, i.e. CDR computerised cognitive test battery, COWAT and CFT [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Pharmacokinetics of ORM-12741, metabolites and AChE inhibitor [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Determination of ORM-12741, metabolites and acetylcholinesterase inhibitor concentrations in plasma
Scores on Cornell Scale for Depression in Dementia CSDD [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Scores on Cognitive Failures Questionnaire CFQ [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Scores on Clinical Global Impression of Change CGI-C [ Time Frame: 3 months ] [ Designated as safety issue: No ]


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)
Genders Eligible for Study:	Both
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

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:

A poster of the study results This link exits the ClinicalTrials.gov site

AAN 65th ANNUAL MEETING ABSTRACT This link exits the ClinicalTrials.gov site


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
Health Authority:	Finland: Finnish Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios

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 23, 2016

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