Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease (ALPO)
1 april 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Turku, Finland, 20520
- Clinical Research Services Turku (CRST)
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
55 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Placebo
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Placebo twice a day
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Experimentell: Low dose of ORM-12741
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60mg twice a day
200mg twice a day
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Experimentell: High dose of ORM-12741
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60mg twice a day
200mg twice a day
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants With Adverse Events
Tidsram: 3 months
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Adverse events from start of ORM-12741 treatment until end of study visit.
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3 months
|
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Quality of Episodic Memory
Tidsram: 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.
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3 months
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Quality of Working Memory
Tidsram: 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
|
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Quality of Memory
Tidsram: 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.
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3 months
|
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Speed of Memory
Tidsram: 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.
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3 months
|
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Power of Attention
Tidsram: 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.
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3 months
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Continuity of Attention
Tidsram: 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.
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3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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NPI Total Score
Tidsram: 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.
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3 months
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Caregiver Distress Score
Tidsram: 3 months
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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.
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3 months
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Pharmacokinetics of ORM-12741
Tidsram: 3 months
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ORM-12741 plasma trough concentrations at week 12.
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3 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Juha Rinne, Prof, Clinical Research Services Turku (CRST)
Publikationer och användbara länkar
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2011
Primärt slutförande (Faktisk)
1 september 2012
Avslutad studie (Faktisk)
1 oktober 2012
Studieregistreringsdatum
Först inskickad
24 mars 2011
Först inskickad som uppfyllde QC-kriterierna
25 mars 2011
Första postat (Uppskatta)
29 mars 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 april 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 april 2021
Senast verifierad
1 april 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 3098006
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