Depletion of Serum Amyloid P Component in Alzheimer's Disease (v1.0)

  • Research type

    Research Study

  • Full title

    DEpletion of Serum amyloid P component In Alzheimer’s Disease: DESPIAD. Double-blind placebo controlled randomised phase IIb trial of SAP depletion by CPHPC in mild Alzheimer’s disease.

  • IRAS ID

    191279

  • Contact name

    Martin Rossor

  • Contact email

    m.rossor@ucl.ac.uk

  • Eudract number

    2016-003284-19

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    Alzheimer’s disease (AD) is one of the most important and most costly unmet medical needs in developed countries. Serum Amyloid P component (SAP) a normal human protein produced exclusively in the liver is found in abnormally high levels in the brain of AD patients. CPHPC (Investigational Medicinal Product) is a SAP reducing drug. This trial aims to determine whether SAP reduction improves established clinical and other measures of AD. New insight into AD could inform therapeutic developments.

    This placebo-controlled phase IIb trial will explore the safety, tolerability and potential effectiveness of CPHPC or placebo. Administration is given via subcutaneous injection, three times a day. The chance of receiving either is random. Allocation of either arm is also unknown to both the participant and trial team.
    Main criteria for participants to be eligible for the trial: able to provide written consent; aged between 50-85 inclusive; clinical diagnosis of mild AD as determined by the neurological test (Mini Mental State Exam 20-28) and brain imaging; living with a partner, relative or carer able to attend appointments and to assist with dosing; adequate understanding of written and verbal information in English; certain medications are precluded.

    Patient identification centres may be added to provide information (but not consent) and refer participants to the study. Participants will be required to attend the Leonard Wolfson Experimental Neurology Centre (LWENC) for full trial participation. However, additional sites may be required in the future. If additional sites are added, REC will be informed and the necessary amendments will be submitted.

    The trial will last for 3 years. Treatment will last twelve months with one additional one month follow up visit post treatment. Participants will need to attend a minimum of eleven clinic visits and a phone call at various points throughout the trial. Assessments will include imaging scans, lumbar puncture procedures, blood and urine tests and a test of the heart's rhythm and electrical activity (ECG).

  • REC name

    South Central - Berkshire B Research Ethics Committee

  • REC reference

    16/SC/0590

  • Date of REC Opinion

    24 Jan 2017

  • REC opinion

    Further Information Favourable Opinion