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

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: S47445 15mg; Drug: S47445 50mg; Drug: S47445 5mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02626572

CL2-47445-011

2014-001519-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 4 patient groups, including a placebo group

S47445 5mg

Experimental group

Treatment:

Drug: S47445 5mg

S47445 15mg

Experimental group

Treatment:

Drug: S47445 15mg

S47445 50mg

Experimental group

Treatment:

Drug: S47445 50mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo