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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

March 24, 2011
October 20, 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01324518 on ClinicalTrials.gov Archive Site
  • 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 ]
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
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
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01324518
3098006
Yes
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