← Trials/Trial dossier/NCT01324518

ALPO

CompletedPhase 2Results posted

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

Lead sponsor

Orion Corporation, Orion Pharma

Asset

ORM-12741

Listed sites

Recruiting sites

Enrollment

100

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-21

Primary endpoints

•Adverse Events•Quality of Episodic Memory•Quality of Working Memory

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 ID3098006

NCT IDNCT01324518

Timeline

Milestones

Study first posted2011-03-29estimated

Study start2011-04actual (month precision)

Primary completion2012-09actual (month precision)

Study completion2012-10actual (month precision)

Last update posted2021-04-28actual

Results first posted2021-04-28actual

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

•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

Endpoints (20)

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

Memory

Executive function / language

Behavior / neuropsychiatric

Safety / tolerability / PK

Memory

8 endpoints

Primary/protocol endpoint

Quality of Episodic Memory

Time frame:3 months

descriptive

Primary/registry result

Quality of Episodic Memory

Time frame:3 months

descriptive

Posted result

Group	Value (mean), Index score	Standard deviation
Low Dose of ORM-12741n=24 Participants	100.7	92.2
High Dose of ORM-12741n=26 Participants	85.0	59.6
Placebon=28 Participants	46.3	62.4

Primary/protocol endpoint

Quality of Working Memory

Time frame:3 months

descriptive

Primary/registry result

Quality of Working Memory

Time frame:3 months

descriptive

Posted result

Group	Value (mean), Index score	Standard deviation
Low Dose of ORM-12741n=24 Participants	1.20	0.53
High Dose of ORM-12741n=26 Participants	1.18	0.47
Placebon=28 Participants	0.82	0.59

Primary/protocol endpoint

Quality of Memory

Time frame:3 months

descriptive

Primary/registry result

Quality of Memory

Time frame:3 months

descriptive

Posted result

Group	Value (mean), Index score	Standard deviation
Low Dose of ORM-12741n=24 Participants	216.53	133.15
High Dose of ORM-12741n=26 Participants	196.37	93.72
Placebon=28 Participants	117.15	104.30

Primary/protocol endpoint

Speed of Memory

Time frame:3 months

descriptive

Primary/registry result

Speed of Memory

Time frame:3 months

descriptive

Posted result

Group	Value (mean), msec	Standard deviation
Low Dose of ORM-12741n=24 Participants	8287.8	3898.2
High Dose of ORM-12741n=26 Participants	8930.30	5379.5
Placebon=28 Participants	8082.2	4064.1

Executive function / language

4 endpoints

Primary/protocol endpoint

Power of Attention

Time frame:3 months

descriptive

Primary/registry result

Power of Attention

Time frame:3 months

descriptive

Posted result

Group	Value (mean), msec	Standard deviation
Low Dose of ORM-12741n=25 Participants	1940.3	533.3
High Dose of ORM-12741n=26 Participants	1978.0	1040.4
Placebon=28 Participants	2077.9	995.8

Primary/protocol endpoint

Continuity of Attention

Time frame:3 months

descriptive

Primary/registry result

Continuity of Attention

Time frame:3 months

descriptive

Posted result

Group	Value (mean), Index score	Standard deviation
Low Dose of ORM-12741n=25 Participants	85.7	11.0
High Dose of ORM-12741n=26 Participants	84.8	15.3
Placebon=28 Participants	79.7	21.2

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

NPI Total Score

Time frame:3 months

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Caregiver Distress Score

Time frame:3 months

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/registry result

NPI Total Score

Time frame:3 months

Neuropsychiatric Inventory (NPI)

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
Low Dose of ORM-12741n=25 Participants	14.7	9.1
High Dose of ORM-12741n=26 Participants	13.7	8.9
Placebon=28 Participants	20.2	19.0

Secondary/registry result

Caregiver Distress Score

Time frame:3 months

Neuropsychiatric Inventory (NPI)

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
Low Dose of ORM-12741n=25 Participants	9.2	6.0
High Dose of ORM-12741n=26 Participants	8.0	4.3
Placebon=28 Participants	11.0	10.4

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of Participants With Adverse Events

Time frame:3 months

event count, event

Primary/registry result

Number of Participants With Adverse Events

Time frame:3 months

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Low Dose of ORM-12741n=33 Participants	18	-
High Dose of ORM-12741n=33 Participants	21	-
Placebon=34 Participants	21	-

Secondary/protocol endpoint

Pharmacokinetics of ORM-12741

Time frame:3 months

concentration, descriptive

Secondary/registry result

Pharmacokinetics of ORM-12741

Time frame:3 months

concentration, descriptive

Posted result

Group	Value (mean), ng/ml	Standard deviation
Low Dose of ORM-12741n=29 Participants	18.4	13.9
High Dose of ORM-12741n=31 Participants	61.0	45.9
Placebon=32 Participants	0	0

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.