Alzheimer's DiseasePhase 2ALPONCT01324518

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

A Phase 2 study testing ORM-12741 in people with Alzheimer's Disease, run by Orion Corporation, Orion Pharma at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 55 to 90 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: ORM-12741
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteFinland
Study dates: Apr 2011to Oct 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

Finland1 site

Clinical Research Services Turku (CRST)
Turku, 20520

Other trials in Finland

About this study

Official title: Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease

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

Read the detailed description

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

Conditions: Alzheimer's Disease
Being tested: ORM-12741, Placebo for ORM-12741
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ORM-12741Drug
60mg twice a day
ORM-12741Drug
200mg twice a day
Placebo for ORM-12741Drug
Placebo twice a day

Study groups in NCT01324518
Study group	Role	What they receive
Low dose of ORM-12741	Experimental	Not described Receives: Drug: ORM-12741
High dose of ORM-12741	Experimental	Not described Receives: Drug: ORM-12741
Placebo	Placebo comparator	Not described Receives: Drug: Placebo for ORM-12741

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
Adverse events from start of ORM-12741 treatment until end of study visit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months

Secondary outcomes (3)

NPI Total Score
The total score of Neuropsychiatric Inventory (NPI) was assessed by a caregiver interview. 10 behavioral areas were included: Delusions, Hallucinations, Agitation/Aggression, Depression/Dysphoria, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability/Lability, and Aberrant Motor Behaviour. Higher scores mean worse outcome. Minimum value 0, maximum value 120.
Measured: 3 months
Caregiver Distress Score
Caregiver distress score generated by adding together the scores of individual NPI distress questions of Neuropsychiatric Inventory NPI. Higher scores mean worse outcome. Minimum value 0, maximum value 120.
Measured: 3 months
Pharmacokinetics of ORM-12741
ORM-12741 plasma trough concentrations at week 12.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Oct 2012

First posted29 Mar 2011 (estimated)
Study startApr 2011
Primary completionSep 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01324518
Sponsor's protocol ID: 3098006
Acronym: ALPO
Status last verified: Apr 2021
First submitted: 24 Mar 2011
Last updated: 28 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease
ClinicalTrials.gov ID: NCT01324518
Acronym / sponsor ID: ALPO / 3098006
Conditions: Alzheimer's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
Study start: Apr 2011 (actual)
Primary completion: Sep 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 29 Mar 2011 (estimated)
Results: Posted 28 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 55 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ORM-1274160mg twice a day	Drug	Low dose of ORM-12741
ORM-12741200mg twice a day	Drug	High dose of ORM-12741
Placebo for ORM-12741Placebo twice a day	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events
Time frame: 3 months
Adverse events from start of ORM-12741 treatment until end of study visit.
Quality of Episodic Memory
Time frame: 3 months
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.
Quality of Working Memory
Time frame: 3 months
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.
Quality of Memory
Time frame: 3 months
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.
Speed of Memory
Time frame: 3 months
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.
Power of Attention
Time frame: 3 months
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.
Continuity of Attention
Time frame: 3 months
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 secondary outcomes

NPI Total Score
Time frame: 3 months
Caregiver Distress Score
Time frame: 3 months
Pharmacokinetics of ORM-12741
Time frame: 3 months

Results and safety

Results posted to the registry on 28 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose of ORM-12741	33	28
High Dose of ORM-12741	33	30
Placebo	34	33

Primary outcome: Number of Participants With Adverse Events

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Low Dose of ORM-12741 n = 33	High Dose of ORM-12741 n = 33	Placebo n = 34
Value	18	21	21

Primary outcome: Quality of Episodic Memory

Time frame: 3 months. Mean (Standard Deviation). Unit: Index score

Measure	Low Dose of ORM-12741 n = 24	High Dose of ORM-12741 n = 26	Placebo n = 28
Value	100.7 (92.2)	85.0 (59.6)	46.3 (62.4)

Population analysed: per protocol population

Primary outcome: Quality of Working Memory

Time frame: 3 months. Mean (Standard Deviation). Unit: Index score

Measure	Low Dose of ORM-12741 n = 24	High Dose of ORM-12741 n = 26	Placebo n = 28
Value	1.20 (0.53)	1.18 (0.47)	0.82 (0.59)

Population analysed: per protocol population

Primary outcome: Quality of Memory

Time frame: 3 months. Mean (Standard Deviation). Unit: Index score

Measure	Low Dose of ORM-12741 n = 24	High Dose of ORM-12741 n = 26	Placebo n = 28
Value	216.53 (133.15)	196.37 (93.72)	117.15 (104.30)

Population analysed: per protocol population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose of ORM-12741	0 of 33 (0%)	8 of 33 (24.2%)	0 of 33
High Dose of ORM-12741	1 of 33 (3%)	14 of 33 (42.4%)	0 of 33
Placebo	0 of 34 (0%)	16 of 34 (47.1%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AAN 65th ANNUAL MEETING ABSTRACTLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juha Rinne, Prof principal investigator

Clinical Research services Turku (CRST)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ORM-12741 in people with Alzheimer's Disease, run by Orion Corporation, Orion Pharma at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01324518.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.