Nebula

CompletedPhase 2

Efficacy of ORM-12741 on Agitation/Aggression Symptoms in Alzheimer's Disease

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

Lead sponsor

Orion Corporation, Orion Pharma

Asset

ORM-12741

Listed sites

Recruiting sites

Enrollment

308

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-24

Primary endpoint

•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID3098012

NCT IDNCT02471196

Timeline

Milestones

Study first posted2015-06-15estimated

Study start2015-08-14actual

Primary completion2017-10-09actual

Study completion2017-12-04actual

Last update posted2018-02-15actual

Assets

Drug assets

ORM-12741

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Behavior / neuropsychiatric

Other (unclassified)

Function / daily living

1 endpoint

Secondary/protocol endpoint

Efficacy on daily living measured by Alzheimer's Disease Co-operative Study - Activities of Daily Living inventory

Time frame:12 weeks

descriptive

Behavior / neuropsychiatric

3 endpoints

Primary/protocol endpoint

Efficacy on aggression/agitation symptoms measured by Neuropsychiatric Inventory Clinician Rating scale

Time frame:12 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

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

categorical status, descriptive

Secondary/protocol endpoint

Efficacy on aggression/agitation symptoms measured by Cohen Mansfield Agitation Inventory

Time frame:12 weeks

descriptive

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Safety measured by assessing adverse events

Time frame:12 weeks

event count, event

Secondary/protocol endpoint

Safety measured by vital signs

Time frame:12 weeks

descriptive

Secondary/protocol endpoint

Safety measured by electrocardiogram

Time frame:12 weeks

descriptive

Secondary/protocol endpoint

Safety measured by laboratory variables

Time frame:12 weeks

descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Efficacy on cognitive symptoms measured by Cognitive Drug Research computerized test battery

Time frame:12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Plasma concentrations of ORM ORM-12741, metabolites and possible other Alzheimer's disease medication

Time frame:12 weeks

concentration, descriptive

Secondary/protocol endpoint/low confidence

Efficacy on cognitive symptoms measured by Alzheimer's Disease Assessment Scale

Time frame:12 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.