Exploratory study of S38093 in patients with mild to moderate AD.

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  14150

• Sponsor organisation

  Institut de Recherches Internationales Servier (IRIS)

• Eudract number

  2008-007670-37

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Alzheimer's disease (AD) is the most common cause of dementia in Western countries. The occurrence of dementia increases significantly with age even people over 50 years old are at increased risk. This disease causes progressive problems with memory, problem solving and speaking, and with time impairs daily functioning. These problems are together called "cognitive decline". It is crucial to start effective treatment as early as possible, to slow down progress of the disease and maintain function and independence for as long as possible. There are several licensed drug treatments available, but current treatments have modest effects and therefore it is important to research other treatment options through clinical trials. This study will determine whether study medication is safe for patients with Alzheimer's disease. It will also compare the effects of the new treatment with placebo (non active treatment) on improving cognitive decline. During the study participants and their nominated caregivers will attend 7 scheduled study visits over a period of 16-20 weeks. During these visits participants will answer questions about their disease and will perform tests using a computer. Patients will be examined by a study nurse and doctor who will obtain blood and urine samples. If eligible for inclusion in the trial each patient will be randomly assigned to receive the study medication or placebo (non active treatment). In order to make sure that the results are unbiased, neither the patients nor their healthcare team will know this assignment of medication. The study is funded by an international pharmaceutical company. It will be conducted in 7 countries worldwide with total number of around 200 patients. In the UK there will be 7 centres recruiting around 40-50 patients.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/43

• Date of REC Opinion

  24 Mar 2009

• REC opinion

  Favourable Opinion