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

NCT01324518 | Completed Phase 2 Results DMC

• 1 other identifier: 3098006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Adverse Events

  Adverse events from start of ORM-12741 treatment until end of study visit.

  3 months

• Quality of Episodic Memory

  The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Quality of Episodic Memory measures the capability of maintaining information in episodic memory and is assessed as the sum of sensitivity indices from 4 memory tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.

  3 months

• Quality of Working Memory

  The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Quality of Working Memory measures the capability of maintaining information in working memory and is assessed as the sum of sensitivity indices from 2 memory tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.

  3 months

• Quality of Memory

  The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Quality of Memory is a combination of outcome measures Quality of Working Memory \& Quality of Episodic Memory. Values are calculated by a computer and higher scores mean better outcome.

  3 months

• Speed of Memory

  The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Speed of Memory is assessed as the sum of speed measures from 2 memory tasks and 2 recognition tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.

  3 months

• Power of Attention

  The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Power of attention measures speed and attention and is assessed from 3 attentional tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.

  3 months

• Continuity of Attention

  The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.

  3 months

Secondary Outcomes (3)

• NPI Total Score

  3 months

• Caregiver Distress Score

  3 months

• Pharmacokinetics of ORM-12741

  3 months

Study Arms (3)

Low dose of ORM-12741

EXPERIMENTAL

Drug: ORM-12741

High dose of ORM-12741

EXPERIMENTAL

Drug: ORM-12741

Placebo

PLACEBO COMPARATOR

Drug: Placebo for ORM-12741

Interventions

ORM-12741 DRUG

60mg twice a day

Low dose of ORM-12741

Placebo for ORM-12741 DRUG

Placebo twice a day

Placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Clinical Research Services Turku (CRST)

Turku, 20520, Finland

Location

Related Links

• AAN 65th ANNUAL MEETING ABSTRACT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ORM-12741

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Study Director
• Organization: Orion Global Clinical Operations

jutta.hanninen@orionpharma.com

Study Officials

• Juha Rinne, Prof

  Clinical Research services Turku (CRST)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 29, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-04

Locations

FI (1)