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    Summary
    EudraCT Number:2016-003284-19
    Sponsor's Protocol Code Number:CTU/2013/073
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-10-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-003284-19
    A.3Full title of the trial
    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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Depletion of Serum Amyloid P Component In Alzheimer’s Disease
    A.3.2Name or abbreviated title of the trial where available
    Depletion of Serum Amyloid P Component in Alzheimer's Disease (v1.0)
    A.4.1Sponsor's protocol code numberCTU/2013/073
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute of Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College London
    B.5.2Functional name of contact pointChinaza Ezirim
    B.5.3 Address:
    B.5.3.1Street AddressCCTU, Room 206, Wolfson house, 4 Stephenson way
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW1 2HE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0203 549 5438
    B.5.6E-mailc.ezirim@ucl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCPHPC
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCPHPC
    D.3.9.1CAS number 224624-80-A
    D.3.9.3Other descriptive namehexanoyl bis(D)-proline; GSK2315698
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200 to g/ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's disease
    E.1.1.1Medical condition in easily understood language
    Dementia due to Alzheimer's disease
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine the safety, tolerability and potential effectiveness of 52 weeks exposure to CPHPC (investigational product) compared to placebo for the treatment of Alzheimer’s disease.
    E.2.2Secondary objectives of the trial
    Explore the effects of CPHPC on the whole brain, especially the hippocampus using volumetric MRI scans at baseline and 12 months

    Assess any effects of CPHPC on cognition via neurological testing

    MRI at baseline and 12 months to observe any disease modification from CPHPC

    Amyloid Pet-CT to observe levels of amyloid deposit in the brain at baseline and 12 months to find if there will be any difference in levels between treatment arms


    Explore spinal fluid SAP concentrations via lumbar puncture to assess any effects between each treatment arm

    Plasma SAP concentration at 0, 3, 6, 9, 12 and 13 months

    Optional TMS to provide extra information on the effects of CPHPC and SAP depletion on the synaptic function of the brain
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) A clinical diagnosis of mild AD (MMSE 20-28 inclusive);.

    (2) Male or female between 50 – 85 years of age (inclusive);

    (3) Supportive evidence of AD pathology from at least one of the following: MRI brain scan consistent with a diagnosis of AD or florbetapir (18F) PET imaging consistent with a diagnosis of AD.


    (4) Participant must live with a partner, relative or carer who can both attend appointments and assist with dosing of medication by s.c. injection;

    (5) Agree to undergo MRI and PET imaging, and lumbar puncture;

    (6) Ability to provide written informed consent;

    (7) Women of child bearing potential and males with a partner of child bearing potential willing to use effective contraception for the duration and 30 days post completion of trial treatment;

    (8) In the opinion of the CI or delegate, adequate understanding of written and verbal information in English
    E.4Principal exclusion criteria
    (1) Ongoing clinically significant depression, in the opinion of the PI likely to impede completion of the trial, or other diseases or drugs influencing cognition; anti-depressant medication stable for more than 3 months is acceptable;

    (2) Significantly abnormal renal (eGFR <50mls/min/m2) or hepatic enzyme values two fold or greater above the upper limit of the reference range;

    (3) Current use of warfarin, rivaroxaban, apixaban and or dabigatran; low dose aspirin or clopidogrel are permitted.

    (4) Current use of cholinesterase inhibitors or memantine unless maintained on a stable dose for at least 3 months prior to randomisation;

    (5) Use of other experimental drugs within 3 months of randomisation;

    (6) Pregnancy or lactation* (current, or planned in the next 13 months).
    *the safety of CPHPC in pregnancy is unknown. Teratogenicity risks for female partners of males being treated with CPHPC are unknown.

    (7) Any medical condition that could be expected to progress, recur, or change to an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk in the opinion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Consolidated evidence of safety and tolerability of CPHPC as determined by absence of: adverse events, worsened cognition, behavioural changes or MRI changes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Determined by absence of: adverse events, worsened cognition, behavioural changes or MRI changes - all of these will be assessed throughout the trial at trial visits and engagement calls with the trial team.
    E.5.2Secondary end point(s)
    1. Rates of whole brain and hippocampal atrophy using quantitative semi-automated analysis of volumetric MRI of brain scans obtained at baseline and 12 months.

    2. Cognition: A version of the Preclinical Alzheimer Cognitive Composite (PACC), which is a composite score comprising: Face Name Associative Memory Performance, Wechsler Logical Memory (paragraph recall), Mini Mental State Examination (MMSE) and Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale–Revised; verbal fluency; an in-house computer-based reaction time task; Clinical Dementia Rating (CDR), and Neuropsychiatric Inventory (NPI). The tests will be performed at 0, 6, 12, and 13 months.

    3. Other qualitative and quantitative MRI parameters in addition to volumetric MRI sequence obtained at 0 and 12 months including T2, FLAIR, T2*, multi-parametric mapping (MPM), diffusion tensor imaging and magnetization transfer (MT) and proton density. These parameters provide high-resolution maps of grey and white matter microstructure, and so can serve as a biomarker of disease modification by CPHPC.

    4. Amyloid PET-CT: florbetapir (18F) PET-CT by single intravenous dose and scanning at the Institute of Nuclear Medicine, UCLH at 0 (or within the previous 4 weeks), and 12 months.

    5. Lumbar puncture: CSF concentrations of SAP, CPHPC, Aβ1-42, total and phosphorylated τ at 0 and 12 months.

    6. Plasma SAP concentration at 0, 3, 6, 9, 12 and 13 months.

    7. Optional transcranial magnetic stimulation (TMS): (i) theta burst protocol to assess synaptic plasticity; (ii) cholinergic short afferent inhibition protocol at 0, 1, 12 and 13 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time points are specified in detail as described under 'secondary end point(s)' 23-2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Completion of the last participants last visit, complete data collection and resolution of all data queries. MHRA and REC will be notified within 90 days of trial completion.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants will be referred back to their neurologist or GP for standard of care treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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