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Completed

NCT Number: NCT02626572

Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Trial Tech Tecnologia em Pesquisa com Medicamentos, Curitiba, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S47445 5mg

Drug

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).

S47445 15mg

Drug

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).

S47445 50mg

Drug

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).

Placebo

Drug

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).

Primary outcomes

  1. Change from baseline on 11-item ADAS-Cog

    Time frame: 24 weeks of treatment

    Cognition criterion

Secondary outcomes

  1. Activities of Daily Living: Disability Assessment for Dementia (DAD)

    Time frame: baseline, week 12, week 24 and week 52

    Key secondary efficacy criterion

  2. Cognition: 13-item ADAS-Cog

    Time frame: baseline, week 4, week 12, week 24, week 38 and week 52

    Other secondary efficacy criteria

  3. Cognition: Mini-Mental State Examination (MMSE)

    Time frame: baseline, week 12, week 24 and week 52

    Other secondary efficacy criteria

  4. Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD)

    Time frame: baseline, week 4, week 12, week 24, week 38 and week 52

    Other secondary efficacy criteria

  5. Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI)

    Time frame: baseline, week 4, week 12, week 24 and week 52

    Other secondary efficacy criteria

  6. Global Clinic Assessment of Change: Alzheimer's Disease Cooperative Studies-Clinical Global Impression of Change (ADCS-CGIC)

    Time frame: baseline, week 24 and week 52

    Other secondary efficacy criteria

  7. Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds)

    Time frame: baseline, week 4, week 12, week 24, week 38 and week 52

    Other secondary efficacy criteria

  8. Adverse events

    Time frame: through study completion, an average of 1 year

    Safety criterion

  9. Vital signs: heart rate

    Time frame: baseline, week 4, week 12, week 24, week 38 and week 52

    Safety criterion

  10. Vital signs: body temperature

    Time frame: baseline, week 4, week 12, week 24, week 38 and week 52

    Safety criterion

  11. Vital signs: blood pressure

    Time frame: baseline, week 4, week 12, week 24, week 38 and week 52

    Safety criterion

  12. Vital signs: body weight

    Time frame: baseline, week 12, week 24, week 38 and week 52

    Safety criterion

  13. 12-lead ECG

    Time frame: baseline, week 4, week 12, week 24, week 38 and week 52

    Safety criterion

  14. Biological laboratory parameters: number of participants with abnomal laboratory values

    Time frame: baseline, week 4, week 12, week 24, week 38 and week 52

    Safety criterion

  15. Cornell Scale for Depression in Dementia (CSDD, suicide item - item 16)

    Time frame: baseline, week 4, week 12, week 24, week 28, week 38 and week 52

    Safety criterion

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 10, 2015
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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