Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    160
  • sponsor
    AgeneBio
Updated on 9 May 2021
Investigator
Clinical Development
Primary Contact
The Roskamp Institute, Inc (3.7 mi away) Contact
+31 other location
estrogen
positron emission tomography
dementia
antidepressants
antipsychotics
mini-mental state examination
alzheimer's disease
amyloid
amyloidosis
mental state examination
cholinesterase inhibitors
cholinesterase
neuropsychological test
senile plaques
apolipoprotein e
ginkgo biloba
mental deterioration

Summary

The primary objective of the study is to evaluate the efficacy of AGB101 on slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with mild cognitive impairment due to Alzheimer's Disease (MCI due to AD) also known as prodromal AD. Participants will be randomized to receive placebo or AGB101 (220 mg), once daily for 78 weeks. Secondary objectives are to assess the effect of AGB101 compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE) and Functional Activities Questionnaire (FAQ).

Details
Condition Mild Cognitive Impairment, Mild Neurocognitive Disorder, Prodromal Alzheimer's Disease
Treatment Placebo Oral Tablet, AGB101 220 mg tablet
Clinical Study IdentifierNCT03486938
SponsorAgeneBio
Last Modified on9 May 2021

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