Phase 2
Completed N=100
Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease
Source: ClinicalTrials.gov NCT01324518 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants With Adverse Events — 18; 21; 21 Participants
Summary
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
18; 21; 21 | — |
| PRIMARY Quality of Episodic Memory |
100.7; 85.0; 46.3 | — |
| PRIMARY Quality of Working Memory |
1.20; 1.18; 0.82 | — |
| PRIMARY Quality of Memory |
216.53; 196.37; 117.15 | — |
| PRIMARY Speed of Memory |
8287.8; 8930.30; 8082.2 | — |
| PRIMARY Power of Attention |
1940.3; 1978.0; 2077.9 | — |
| PRIMARY Continuity of Attention |
85.7; 84.8; 79.7 | — |
| SECONDARY NPI Total Score |
14.7; 13.7; 20.2 | — |
| SECONDARY Caregiver Distress Score |
9.2; 8.0; 11.0 | — |
| SECONDARY Pharmacokinetics of ORM-12741 |
18.4; 61.0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01324518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.