Study of the Efficacy and Safety of Various Anti-inflammatory Agents in Participants With Mild Co… (NCT04795466) | Clinical Trial Compass
TerminatedPhase 2
Study of the Efficacy and Safety of Various Anti-inflammatory Agents in Participants With Mild Cognitive Impairment or Mild Alzheimer's Disease
Stopped: Terminated by Sponsor
United States, Finland, Iceland34 participantsStarted 2021-10-28
Plain-language summary
The purpose of this platform study was to evaluate the effect of anti-inflammatory agents on cognition in early Alzheimer's disease. Additionally, the safety and tolerability and their effects on central and peripheral inflammation were evaluated. Due to early termination only a single agent could be studied.
Who can participate
Age range45 Years – 90 Years
SexALL
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Inclusion Criteria:
* Male or female, age ≥ 45 years and ≤ 90 years at the time of signing the informed consent;
* Participant has a reliable study partner or caregiver can accompany the participant to all visits;
* 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;
* Confirmed amyloid and tau positivity via CSF sampling performed at screening;
* Mini-Mental State Examination (MMSE) total score of 20 to 24 (inclusive) at screening; OR, MMSE total score of 25-30 (inclusive) plus a DSST score at least 0.5 standard deviation (SD) below normative data at screening.
Exclusion Criteria:
* 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 prior to screening, whichever is longer
* Previous use of monoclonal or polyclonal antibodies or other biologics is allowed if discontinued for at least five half-lives prior to screening
* Current medical or neurological condition that 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 majo…
What they're measuring
1
Change From Baseline in Cognition as Measured by the Neuropsychological Test Battery (NTB) Z-scores