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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01324518
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : October 21, 2014
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

March 24, 2011
March 29, 2011
October 21, 2014
April 2011
September 2012   (Final data collection date for primary outcome measure)
  • Safety measures, i.e. assessing adverse events, vital signs, ECG,safety laboratory values [ Time Frame: 3 months ]
  • 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.
Same as current
Complete list of historical versions of study NCT01324518 on Archive Site
  • Scores on Neuropsychiatric Inventory NPI assessment scale [ Time Frame: 3 months ]
  • Pharmacokinetics of ORM-12741, metabolites and AChE inhibitor [ Time Frame: 3 months ]
    Determination of ORM-12741, metabolites and acetylcholinesterase inhibitor concentrations in plasma
  • Scores on Cornell Scale for Depression in Dementia CSDD [ Time Frame: 3 months ]
  • Scores on Cognitive Failures Questionnaire CFQ [ Time Frame: 3 months ]
  • Scores on Clinical Global Impression of Change CGI-C [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease
Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: ORM-12741
    60mg twice a day
  • Drug: ORM-12741
    200mg twice a day
  • Drug: Placebo for ORM-12741
    Placebo twice a day
  • Experimental: Low dose of ORM-12741
    Intervention: Drug: ORM-12741
  • Experimental: High dose of ORM-12741
    Intervention: Drug: ORM-12741
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo for ORM-12741
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Orion Corporation, Orion Pharma
Orion Corporation, Orion Pharma
Not Provided
Principal Investigator: Juha Rinne, Prof Clinical Research services Turku (CRST)
Orion Corporation, Orion Pharma
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP