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

niversity College London0 个研究点开始时间: 2016年10月3日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•(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
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•(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.

发起方

niversity College London