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Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms
Servier Protocol Code:
CL2-47445-011
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT02626572
EudraCT Number:
2014-001519-38
Find a recruiting site
How to participate in this study
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 78 locations
Study description
The purpose of this trial is to assess the efficacy and safety of S47445 versus placebo in patients with Alzheimer's disease at mild to moderate stages with depressive symptoms. An optional 28-week extension period will be performed to evaluate safety/tolerance and efficacy of S47445 in co-administration with donepezil.
Official title: Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms. A 24-week International, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase II Study in Monotherapy Followed by an Optional 28-week Extension Period in Co-administration With Donepezil.
Results
English (USA)Conditions
Alzheimer's Disease
Interventions / Treatments
The treatment(s) given to the participants in the study.
- S47445 5mg
- S47445 15mg
- S47445 50mg
- Placebo
Other study id numbers
Other identification numbers the study may be known by.
- CL2-47445-011
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
55 years to 85 years
(Adult, Older Adult)
Sex
Male/FemaleAccepts Healthy Volunteers
No- * Out-patients
- * Able to perform neuropsychological tests
- * Have a responsible informant
- * DSM-IV-TR criteria for Dementia of the Alzheimer's Disease Type
- * Mini mental State Examination (MMSE) = 15-24 both inclusive
- * National Institute of Mental Health (NIMH) provisional criteria for depression in AD (NIMH-dAD)
- * Cornell Scale for Depression in Dementia total score > or = 8
- * Patients who have never been treated with AD treatments or patients who have stopped AD treatment whatever the reason
- * Patients either not currently treated with an antidepressant or patients being treated with an antidepressant at the recommended dose for at least 8 weeks without clinical efficacy, who can stop this treatment according to the investigator's opinion.
- * Patients not able to read or write
- * Patients having participated in a study testing disease modifying therapy for AD, or in another study with administration of investigational drug or device within the previous 3 months prior to selection visit
- * Depressive symptoms that, in investigator's judgment, are clearly due to a medical condition other than AD, or are a direct result of non-mood related dementia symptoms
- * History of epilepsy or solitary seizure
- * Medical history of Major Depressive Disorder more than 3 years before onset of the disease, treated with antidepressive drugs or electroconvulsive therapy
- * Severe or unstable disease of any type that could interfere with safety and efficacy assessments
- * Alcohol abuse or drug abuse or addiction, as judged by the clinician (excluding nicotine)
- * Clinically relevant lactose intolerance
- * Antidepressant treatment not stopped for at least 3 weeks before inclusion
- * Significant worsening of depressive symptoms or high suicidal risk according to investigator's judgment
- * For optional extension phase: medically instable Chronic Obstructive Pulmonary Disease and asthma, known hypersensitivity to donepezil hydrochloride or piperidine derivatives
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Parallel
A parallel study design compares two or more groups at the same time, with each group receiving a different treatment. Researchers then compare the results to determine which treatment is more effective.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
S47445 5mg
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
S47445 5mg
S47445 5 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
S47445 15mg
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
S47445 15mg
S47445 15 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
S47445 50mg
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
S47445 50mg
S47445 50 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Placebo Comparator:
Placebo
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Placebo
Placebo tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
Keywords
Additional Relevant MeSH Terms Glioma
Alzheimer Disease