Phase 3
N=164
Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease
Mild Cognitive Impairment · Prodromal Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT03486938 ↗Enrolled (actual)
164
Serious AEs
14.3%
Results posted
May 2024
Primary outcome: Primary: Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score From Baseline — 1.1; .9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo Oral Tablet (Drug); AGB101 220 mg tablet (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- AgeneBio
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score From Baseline |
1.1; .9 | — |
| SECONDARY Change in Mini Mental Status Exam (MMSE) Score From Baseline |
-1.9; -2.2 | — |
| SECONDARY Change in Functional Activities Questionnaire (FAQ) Score From Baseline |
3.6; 4 | — |
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).
Eligibility Criteria
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 all the clinic visits for the duration of each visit, and who is able to provide an independent evaluation of the subject's functioning
- Have MCI due to AD 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 9 suggests depression) results should be reviewed by the investigator to assist in this determination.
- Modified Hachinski Ischemic Scale (HIS) score >4
- History of schizophrenia (DSM-5 criteria)
- History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria)
- Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements.
- Clinically significant abnormalities in B12 or thyroid function test that might interfere with the study.
A low B12 (below normative range for elderly) is exclusionary, unless follow-up labs (homocysteine and methylmalonic acid) indicate that it is not physiologically significant. If the B12 deficiency is treated, subjects may become eligible to participate in the study.
- Residence in a skilled nursing facility. Individuals in independent living communities, assisted living facilities, residential care facilities, or continuing care communities are eligible provided they engage in a sufficient spectrum of activity to permit assessment of all 6 domains contributing to the CDR-SB. Individuals in these facilities must also have a caregiver who has the ability to observe the subject during the study and can participate in clinical evaluations.
- Any use of excluded medications (e.g., antiepileptics, certain antidepressants or antipsychotics, antihistamines with anticholinergic properties, opiates)
- Participation in clinical studies using the ISLT, Behavioral Pattern Separation (BPS-O) task, or the trail making test (A, B) within 1 month of screening
- Female subjects must not be pregnant, lactating, or of childbearing potential (i.e., they must be 2 years post menopause or surgically sterile)
Data sourced from ClinicalTrials.gov (NCT03486938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.