Exploratory study of S 38093 versus placebo in patients with mild to moderate Alzheimer’s Disease. An international, multi-centre, randomised, double-blind, placebo-controlled phase IIa study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-007670-37-DE

Enrollment

200

Registered

2009-03-03

Start date

2009-07-07

Completion date

Unknown

Last updated

2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease

Interventions

Product Name: S38093 Product Code: S38093 Pharmaceutical Form: Film-coated tablet Current Sponsor code: S38093 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Ph

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age 55-85 years (inclusive), - male or female, - with cognitive impairment, MMSE 15-26 (inclusive), Clinical Dementia Ratings global score > or = 0.5 (memory sub-score > or = 1.0) - out-patients, defined for the present study as ambulatory or ambulatory with aids, - with a minimum of 5 years of school education, - with a caregiver. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Dementia due to any condition other than Alzheimer's Disease, - History or presence of Parkinson’s disease or Parkinsonism, - Cerebral vascular disorders (stroke, TIA, etc.), - Epilepsy or solitary seizure - Advanced, severe, progressive,, or unstable disease of any type that could interfere with safety and efficacy assessments or put the patient at particular risk.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: ;Main Objective: - safety of S 38093 as compared to placebo, - efficacy of S 38093 on cognitive performances, on neuropsychiatric symptoms and symptoms associated with dementia (including apathy and daytime sleepiness) and on the Clinical Global Impression of Change as compared to placebo, - S 38093 plasma concentrations which will be used for a population pharmacokinetic analysis;Primary end point(s): - Safety criteria: adverse events, vital signs, body weight, 12 lead-ECG, biological laboratory examinations. - Efficacy criteria: Cognitive tasks using a computerised test battery, Clinical Global Impression of Change (ADCS-CGIC), Neuro-Psychiatric Inventory (NPI), Apathy Evaluation Scale (AES), Epworth Sleepiness Scale (ESS). - S 38093 plasma concentrations	—

Measure

Time frame

Secondary Objective: ;Main Objective: - safety of S 38093 as compared to placebo, - efficacy of S 38093 on cognitive performances, on neuropsychiatric symptoms and symptoms associated with dementia (including apathy and daytime sleepiness) and on the Clinical Global Impression of Change as compared to placebo, - S 38093 plasma concentrations which will be used for a population pharmacokinetic analysis;Primary end point(s): - Safety criteria: adverse events, vital signs, body weight, 12 lead-ECG, biological laboratory examinations. - Efficacy criteria: Cognitive tasks using a computerised test battery, Clinical Global Impression of Change (ADCS-CGIC), Neuro-Psychiatric Inventory (NPI), Apathy Evaluation Scale (AES), Epworth Sleepiness Scale (ESS). - S 38093 plasma concentrations

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Countries

Austria, Germany, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026