A Phase 2 interventional study of AGB101 220 mg and Placebo in APOE 4, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Medical College of Wisconsin · Phase 2, Interventional, and Prevention
The purpose of this project is to test the hypothesis that AGB101 low dose levetiracetam extended release formulation can reduce abnormal hyperfunctional activity in the hippocampus in normal, healthy adults. The investigators will compare the functional connectivity results after taking AGB101 or placebo.
In this study the investigators want to find out whether the use of a perturbation, such as AGB101 low dose of levetiracetam extended release formulation, in healthy adults can reduce abnormal hippocampal network activity. The investigators also want to study whether this low dose of LEV can improve memory function.
Generic levetiracetam is a type of drug called an anti-epileptic or anti-seizure medication. It is FDA approved worldwide for adults and children as young as one month with seizures. It is a generic drug used in long-term epilepsy treatment. It is relatively safe and has an acceptable side-effect profile.
AGB101 has been developed as a novel extended release formulation of low dose levetiracetam (below clinically marketed doses for epilepsy) for slowing the progression of amnestic mild cognitive impairment.
It is known that age and the APOE 4 gene are important risk factors for late-onset Alzheimer's disease. Further studies have shown that cognitively normal, older adults have more hyperfunctional brain network activity, increased alpha beta accumulation, decreased memory function, and decreased brain volume, which is consistent with Alzheimer's disease patterns.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's enrollment of 26 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Medical College of Wisconsin is the lead sponsor of 546 studies on the registry; 120 are open to participants now.
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AGB101 220 mg/day capsule, once daily dosing for 2 weeks. After a 4 week washout, to be followed by Placebo, given as a capsule, once daily dosing for 2 weeks.
Drug: AGB101 220 mg · Other: Placebo
Placebo, given as a capsule, once daily for 2 weeks. After a 4 week washout, to be followed by AGB101 220 mg/day capsule, once daily dosing for 2 weeks.
Drug: AGB101 220 mg · Other: Placebo
AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.
Placebo, oral capsule given once-daily.
Functional Connectivity Strengths of Neural Networks
The seed-based functional connectivity strengths of the hippocampus network and the default mode network will be employed to measure the changes between AGB101 and Placebo perturbation. The functional connectivity strengths will be measured with the median of the Pearson cross-correlation coefficients over entire brain regions.
Time frame: 2 weeks after treatment between AGB101 and Placebo
Rey Auditory Verbal Learning Test (AVLT), Delayed Recall Scaled Integer. The Higher is the Better
Rey Auditory Verbal Learning Test (AVLT), delayed recall Scaled integer will be employed to measure the episodic memory changes before and after AGB101 treatment. The AVLT score will be recorded as a standard score. The theoretical range: min 50, max 155, the higher the better. The higher the number is, the better the memory. It is an integer number.
Time frame: Placebo vs AGB101 2 weeks after treatment paired t-test
| Milestone | AGB101 220 mg, Then Placebo | Placebo, Then AGB101 220 mg |
|---|---|---|
| Started | 13 | 13 |
| Completed | 13 | 13 |
| Not completed | 0 | 0 |
The seed-based functional connectivity strengths of the hippocampus network and the default mode network will be employed to measure the changes between AGB101 and Placebo perturbation. The functional connectivity strengths will be measured with the median of the Pearson cross-correlation coefficients over entire brain regions.
| Pearson coefficient | AGB101 220 mg | Placebo |
|---|---|---|
| Functional Connectivity Strengths of Neural Networks | 0.233 ± 0.132 | 0.318 ± 0.127 |
Rey Auditory Verbal Learning Test (AVLT), delayed recall Scaled integer will be employed to measure the episodic memory changes before and after AGB101 treatment. The AVLT score will be recorded as a standard score. The theoretical range: min 50, max 155, the higher the better. The higher the number is, the better the memory. It is an integer number.
| score on a scale | AGB101 220 mg | Placebo |
|---|---|---|
| Rey Auditory Verbal Learning Test (AVLT), Delayed Recall Scaled Integer. The Higher is the Better | 108 ± 17 | 105 ± 16 |
Collected over From Baseline Visit Through 4 Week Follow Up Call (an average of 12 weeks). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AGB101 220 mg | 0/26 (0%) | 0/26 (0%) | 6/26 (23.1%) |
| Placebo | 0/26 (0%) | 0/26 (0%) | 3/26 (11.5%) |
| Event | AGB101 220 mg | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 2/26 | 1/26 |
| SleepinessGeneral disorders | 1/26 | 0/26 |
| Brain ZapsNervous system disorders | 0/26 | 1/26 |
| Visual AuraNervous system disorders | 0/26 | 1/26 |
| Cold SymptomsInfections and infestations | 1/26 | 0/26 |
| Feeling JitteryNervous system disorders | 1/26 | 0/26 |
| Depressed MoodPsychiatric disorders | 1/26 | 0/26 |
One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
| Age, Categorical(Participants) | AGB101 220 mg, Then Placebo | Placebo, Then AGB101 220 mg | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 4 | 9 |
| >=65 years | 8 | 8 | 16 |
| Age, Continuous(years) | AGB101 220 mg, Then Placebo | Placebo, Then AGB101 220 mg | Total |
|---|---|---|---|
| Mean | 66 ± 4 | 67 ± 5 | 66.2 ± 4.5 |
| Sex: Female, Male(Participants) | AGB101 220 mg, Then Placebo | Placebo, Then AGB101 220 mg | Total |
|---|---|---|---|
| Female | 9 | 6 | 15 |
| Male | 4 | 6 | 10 |
| Ethnicity (NIH/OMB)(Participants) | AGB101 220 mg, Then Placebo | Placebo, Then AGB101 220 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 13 | 12 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AGB101 220 mg, Then Placebo | Placebo, Then AGB101 220 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 13 | 12 | 25 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | AGB101 220 mg, Then Placebo | Placebo, Then AGB101 220 mg | Total |
|---|---|---|---|
| United States | 13 | 12 | 26 |
| Apolipoprotein E (APOE) Status(Participants) | AGB101 220 mg, Then Placebo | Placebo, Then AGB101 220 mg | Total |
|---|---|---|---|
| APOE e4 Carrier | 3 | 2 | 5 |
| APOE e4 Non-Carrier | 10 | 10 | 20 |
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Studies of the drug tested here: Levetiracetam
Medical College of Wisconsin →