Evaluate 2 doses of LND101001 in Mild-Moderate Alzheimer's patients
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Comparative, Multicenter, Phase 2 Clinical Study to Evaluate Efficacy and Safety of Two Doses of LND101001 Monotherapy in Patients with Mild to Moderate Alzheimer’s Disease
IRAS ID
167986
Contact name
Ashley Baldwin
Contact email
Sponsor organisation
Lupin Limited
Eudract number
2013-001851-11
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
The purpose of this research study is to test the safety and effectiveness of two different doses of the study medication (LND101001) compared to placebo when given to patients with mild to moderate Alzheimer’s Disease.
Alzheimer’s Disease is the most common type of dementia and the progression of the disease causes changes to the way in which the brain works. This can result in symptoms such as confusion, loss of memory, changes in mood and problems with communication. Currently there is no known cure for Alzheimer’s Disease, however research continues to study new treatments.
This study is due to last for approximately 1 year 10 months, with patient participation expected to last approximately 4 months. This includes 90 days of treatment and follow-up 7 days after the last dose of study medication. Participants will be seen every 30 days during treatment. Study participants will be randomly assigned in to one of three treatment groups, receiving either LND101001 5 mg; LND101001 25 mg; or Placebo for the study duration.
Study participants will include males or females between the ages of 50 to 85 years with mild to moderate Alzheimer’s Disease who have received no treatment or had previous therapy but did not obtain expected improvement of their symptoms or previous therapy was not tolerated well.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0405
Date of REC Opinion
19 Jun 2015
REC opinion
Further Information Favourable Opinion