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: November 6, 2013
Last verified: November 2013
  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
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: November 6, 2013
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014