Clinical Trial of AGB101 for Mild Cognitive Impairment (NCT05986721) | Clinical Trial Compass
WithdrawnPhase 2
Clinical Trial of AGB101 for Mild Cognitive Impairment
Stopped: Sponsor decision
United States0Started 2024-12-03
Plain-language summary
The primary objective of the study is to evaluate the efficacy of AGB101 on slowing cognitive and functional impairment as measured by reduction in neuronal injury in participants with mild cognitive impairment due to Alzheimer's Disease. 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 the Clinical Dementia Rating Scale- Sum of Boxes and Memory Box score.
Who can participate
Age range55 Years – 85 Years
SexALL
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Inclusion criteria
✓. Subjects between 55 and 85 years old (inclusive) in good general health:
✓. Willing and able to consent and participate for the duration of the study.
✓. Have eighth-grade education or good work history sufficient to exclude mental retardation.
✓. Have visual and auditory acuity adequate for neuropsychological testing.
✓. Have proficient fluency of the native local language to participate in all the neuropsychological test assessments.
✓. Have a study partner who has sufficient contact with the subject to be able to provide assessment of memory changes, who can accompany the subject to the screening visit and all major clinic visits for the duration of those visits, and who is able to provide an independent evaluation of the subject's functioning.
✓. Have MCI as defined by all of the following criteria and consistent with the National Institute on Aging-Alzheimer's Association criteria:
✓. MMSE scores between 24 and 30 (inclusive; exceptions may be made for subjects with \<8 years of education at the discretion of the sponsor).
Exclusion criteria
✕. Carrying one or more copies of the apolipoprotein E4 (ApoeE4) allele.
✕. Use of anticonvulsant medications or excluded psychotropic medications within 3 months prior to the baseline visit.
✕. Use of anti-amyloid medications at any time prior to screening visit, or at any time during the study.
What they're measuring
1
Change in Entorhinal Cortex (EC) Volume From Baseline
✕. Participation in a therapeutic clinical study for any medical or psychiatric indications within 3 months (6 months for biologics) of the screening visit, or at any time during the study. Subjects must understand that they may only enroll in this clinical study once; they may not enroll in any other clinical study while participating in the current study, and they may not participate in a clinical study of a drug, biologic, therapeutic device, or medical food, in which the last dose/administration was received within 3 months (6 months for biologics) prior to screening.
✕. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam).
✕. Severe renal impairment (creatinine clearance of \< 30 mL/minute) or undergoing hemodialysis.
✕. Any significant neurological disease other than suspected incipient AD, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder (lifetime history; infant febrile seizures are not exclusionary), subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities.
✕. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body that constitute a contraindication to having an MRI.