Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease (ALPO)
1. april 2021 opdateret af: Orion Corporation, Orion Pharma
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Turku, Finland, 20520
- Clinical Research Services Turku (CRST)
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Placebo twice a day
|
|
Eksperimentel: Low dose of ORM-12741
|
60mg twice a day
200mg twice a day
|
|
Eksperimentel: High dose of ORM-12741
|
60mg twice a day
200mg twice a day
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Adverse Events
Tidsramme: 3 months
|
Adverse events from start of ORM-12741 treatment until end of study visit.
|
3 months
|
|
Quality of Episodic Memory
Tidsramme: 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.
|
3 months
|
|
Quality of Working Memory
Tidsramme: 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.
|
3 months
|
|
Quality of Memory
Tidsramme: 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.
|
3 months
|
|
Speed of Memory
Tidsramme: 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.
|
3 months
|
|
Power of Attention
Tidsramme: 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.
|
3 months
|
|
Continuity of Attention
Tidsramme: 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 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
NPI Total Score
Tidsramme: 3 months
|
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.
|
3 months
|
|
Caregiver Distress Score
Tidsramme: 3 months
|
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.
|
3 months
|
|
Pharmacokinetics of ORM-12741
Tidsramme: 3 months
|
ORM-12741 plasma trough concentrations at week 12.
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Juha Rinne, Prof, Clinical Research Services Turku (CRST)
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2011
Primær færdiggørelse (Faktiske)
1. september 2012
Studieafslutning (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først indsendt
24. marts 2011
Først indsendt, der opfyldte QC-kriterier
25. marts 2011
Først opslået (Skøn)
29. marts 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3098006
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med ORM-12741
-
Orion Corporation, Orion PharmaAfsluttetSund og raskFrankrig
-
Orion Corporation, Orion PharmaAfsluttet
-
Orion Corporation, Orion PharmaAfsluttet
-
Orion Corporation, Orion PharmaAfsluttetSund og raskFrankrig
-
Orion Corporation, Orion PharmaAfsluttet
-
Orion Corporation, Orion PharmaJanssen PharmaceuticalsAfsluttetAlzheimers sygdomFinland
-
Orion Corporation, Orion PharmaAfsluttetSund og raskFrankrig
-
Orion Corporation, Orion PharmaAfsluttetSunde mandlige frivilligeHolland
-
Orion Corporation, Orion PharmaAfsluttet