EXploratory PLatform trial on Anti-INflammatory agents in Alzheimer’s Disease (EXPLAIN-AD): A randomized, placebo controlled, multicenter platform study to evaluate the efficacy, safety, tolerability and pharmacokinetics of various anti-inflammatory agents in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease - EXploratory PLatform trial on Anti-INflammatory agents in Alzheimer’s Disease (EXPLAIN-AD)

ovartis Pharma AG0 个研究点目标入组 900 人开始时间: 2021年4月12日最近更新: 2023年10月3日

适应症

试验速览

暂无简介。

•1. Male or female, age = 45 years and = 90 years at the time of signing the informed consent;
•2. Participant has a reliable study partner or caregiver can accompany the participant to all visits;
•3. A diagnosis of probable MCI due to AD or mild AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria;
•4. Confirmed amyloid and tau positivity via CSF sampling performed at screening;
•5. Mini-Mental State Examination (MMSE) total score of 20 to 30 (inclusive). Participants who score 25 points on MMSE or higher must additionally score at least half a standard deviation (SD) below education adjusted normative data on the DSST at point of screening
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 720

•1. Use of an investigational agent or an approved product with the intent to modulate inflammation or modulate the course of AD (e.g., Tau ASOs, gene therapy, amyloid or tau vaccine):
•previous use of small molecules is allowed if discontinued for at least five half-lives, or at least 30 days from when the expected pharmacodynamic effect has returned to baseline, whichever is longer
•previous use of monoclonal and polyclonal antibodies or other biologics is allowed if discontinued for at least five half-lives prior to screening
•2. Current medical or neurological condition that in the judgement of the investigator might impact cognition or performance on cognitive assessments, e.g., MCI not due to AD, non-Alzheimer dementia, Huntington's disease, Parkinson's disease, stroke, schizophrenia, bipolar disorder, active major depression, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), active seizure disorder, or history of traumatic brain injury associated with loss of consciousness and ongoing residual transient or permanent neurological signs/symptoms including cognitive deficits, and/or associated with skull fracture.
•3. Diagnosis of vascular dementia prior to baseline (e.g.., modified Hachinski Ischaemic Scale score > 6 or those who meet the NINDS AIREN criteria for vascular dementia)

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