Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02471196 |
Date of registration:
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08/06/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy of ORM-12741 on Agitation/Aggression Symptoms in Alzheimer's Disease
Nebula |
Scientific title:
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Efficacy of ORM-12741 on Agitation/Aggression Symptoms in Patients With Alzheimer's Disease: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Study of 12 Weeks |
Date of first enrolment:
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August 14, 2015 |
Target sample size:
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308 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02471196 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Finland
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Contacts
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Name:
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Juha Rinne, Prof |
Address:
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Telephone:
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Email:
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Affiliation:
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Clinical Research Services Turku - CRST Oy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent (IC) for participation in the study (co-signed by the
subject's next of kin or caregiver, or other legally acceptable representative.
- Written IC obtained from a consistently available caregiver informant who is
knowledgeable of the subject's condition and its progression and is willing to
accompany the subject to all visits and supervise the administration of the study
medication.
- Age of 55-90 years (inclusive).
- Male or female subjects with diagnosis of probable Alzheimer's Disease.
- Brain imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
consistent with a diagnosis of Alzheimer's Disease (within 18 months or at screening).
- Mini-mental state examination (MMSE) score between 10-24 (inclusive).
- Clinically significant agitation meeting the International Psychogeriatric Association
Provisional Criteria for Agitation in Cognitive Impairment. The agitation symptoms
need to have been present for at least 4 weeks before the screening visit.
- Neuropsychiatric Inventory agitation/aggression item score at least 4 at screening
visit.
Exclusion Criteria:
- Modified Hachinski Ischemia Score (MHIS) > 4.
- Changes in AChE inhibitor (donepezil, rivastigmine or galantamine) dosing within 2
months prior to screening.
- Changes in memantine dosing within 2 months prior to the screening.
- Changes in antidepressant dosing or addition of another antidepressant medication
within 2 months prior to the screening.
- Use of antipsychotics at any dose within 1 month prior to screening.
- Use of benzodiazepines, other than short-acting sleep medications, for night at a
maximum of 3 nights/week, within 2 months prior to screening.
- Use of any anticholinergic medication within 2 months prior to screening.
- Current use (within the 30 days prior to screening) of medications with known relevant
alpha-2C AR affinity (e.g. mirtazapine, mianserin, clonidine, guanfacine or
tizanidine) or with high noradrenaline transporter affinity (reboxetine, venlafaxine
or duloxetine).
- Current use of other psychotropic agents, unless the dosing has been stable during the
last 2 months prior to the screening.
- Myocardial infarction or other clinically significant ischemic cardiac disease, heart
failure, or arrhythmia tendency within the past 2 years.
- Current or history of malignancy within 5 years before screening.
- Suicidal ideation in the 6 months before screening or current suicide risk based on
the Colombia-Suicide Severity Rating Scale (C-SSRS) (items 4 and 5 exclusionary) or
current risk of suicide based on the investigator's judgement.
- Specific findings in MRI or CT that could in the opinion of the investigator affect
cognitive function (such as cortical infarct or silent lacuna in a region known to
affect cognition).
- Supine heart rate < 48 bpm or > 100 bpm.
- Systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg
after a 5-minute rest.
- Symptomatic orthostatic hypotension.
- QTc-Fridericia (QTcF) repeatedly > 450 ms in males or > 470 ms in females.
- Clinically significantly abnormal thyroid-stimulating hormone (TSH), vitamin B12 or
folate serum levels at screening.
- Resides in a skilled nursing facility.
Age minimum:
55 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Intervention(s)
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Drug: ORM-12741
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Drug: Placebo
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Primary Outcome(s)
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Efficacy on aggression/agitation symptoms measured by Neuropsychiatric Inventory Clinician Rating scale
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Plasma concentrations of ORM ORM-12741, metabolites and possible other Alzheimer's disease medication
[Time Frame: 12 weeks]
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Safety measured by laboratory variables
[Time Frame: 12 weeks]
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Safety measured by electrocardiogram
[Time Frame: 12 weeks]
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Safety measured by vital signs
[Time Frame: 12 weeks]
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Efficacy on cognitive symptoms measured by Alzheimer's Disease Assessment Scale
[Time Frame: 12 weeks]
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Efficacy on cognitive symptoms measured by Cognitive Drug Research computerized test battery
[Time Frame: 12 weeks]
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Efficacy on daily living measured by Alzheimer's Disease Co-operative Study - Activities of Daily Living inventory
[Time Frame: 12 weeks]
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Efficacy on aggression/agitation symptoms and overall clinical status measured by Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change
[Time Frame: 12 weeks]
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Safety measured by assessing adverse events
[Time Frame: 12 weeks]
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Efficacy on aggression/agitation symptoms measured by Cohen Mansfield Agitation Inventory
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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