Study of Memantine in Memory, Concentration or Attention Problems

• Research type

  Research Study

• Full title

  Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of 10mg memantine in the treatment of memory, concentration or attention problems (subjective cognitive impairment) in the absence of dementia

• IRAS ID

  59302

• Contact name

  Roy Jones

• Sponsor organisation

  Merz Pharmaceuticals GmbH

• Eudract number

  2010-020737-50

• ISRCTN Number

  n/a

• Research summary

  This is a multicenter study to investigate the effectiveness and safety of a drug called memantine in the treatment of memory, concentration or attention problems in the absence of dementia. Memantine is currently prescribed, at a higher dose than in this study, for patients with moderate to severe Alzheimer’s disease. Approximately 300 male and female patients with complaints of memory, concentration, or attention problems, aged 50 to 80, will take part in this study from clinics in Great Britain and Germany. Participants will be randomly (i.e. by chance, like the flip of a coin) assigned to one of two treatment groups. One group will receive tablets of the study drug, memantine, and the other group will receive placebo (a dummy drug that looks like the study drug but contains no active ingredients) tablets. Each participant will be in the study for approximately 17 weeks. An initial Screening Visit will be followed by a 12 week Treatment Phase. Four weeks later participants will attend a Follow-up visit. During their participation in the study the patients’ demographic data & medical history will be recorded, their weight will be measured and several questionnaires will need to be completed. There is no guarantee that the participants will benefit from taking part in the study but it is hoped that the results from this study will help in the future treatment of patients with memory, concentration or attention problems in the absence of dementia.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  10/H0504/58

• Date of REC Opinion

  10 Nov 2010

• REC opinion

  Further Information Favourable Opinion