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

This study has been completed.
Sponsor:
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
  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:


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
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:
No publications provided

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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 29, 2014