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AGB101 for Mild Cognitive Impairment

CW
Overseen ByCarrie Wagandt
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AgeneBio
Must be taking: Cholinesterase inhibitors, Memantine
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that certain medications be at a stable dose for a specific period before and during the study. If you are taking medications with potential pro-cognitive effects, antidepressants, or antipsychotics, they must be stable for at least 3 months before screening. Other medications like estrogen replacement therapy, Ginkgo biloba, and vitamin E must be stable for at least 4 weeks before screening. Some medications, such as anticonvulsants and certain psychotropics, are not allowed.

What evidence supports the effectiveness of the drug AGB101 for mild cognitive impairment?

Levetiracetam, a component of AGB101, has been shown to improve cognitive deficits in Alzheimer's disease and mild cognitive impairment by reducing excess neural activity in the brain, which is linked to memory loss. Additionally, it does not negatively impact cognitive function in patients with epilepsy, suggesting it may be beneficial for cognitive health.12345

Is AGB101 (Levetiracetam) safe for humans?

Levetiracetam, also known as AGB101 or Keppra, has been studied extensively for epilepsy and is generally considered safe for humans. Most side effects are mild to moderate, and it does not impair cognitive function or cause weight gain, though some people may experience behavioral changes.36789

How does the drug AGB101 (Levetiracetam) differ from other treatments for mild cognitive impairment?

AGB101 (Levetiracetam) is unique because it targets excess neural activity in the hippocampus, which is linked to cognitive decline in conditions like mild cognitive impairment and Alzheimer's disease. Unlike other treatments, it reduces this hyperactivity without negatively impacting cognitive function, potentially improving memory and slowing disease progression.2341011

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with mild cognitive impairment due to Alzheimer's, who can consent and participate for 78 weeks. They should have at least an eighth-grade education or equivalent work history, adequate sensory abilities for testing, a study partner to assist them, MMSE scores of 24-30, and a specific memory complaint.

Inclusion Criteria

I have someone who knows me well to attend major clinic visits and assess my memory changes.
You are able to provide consent and commit to the study's duration.
You have completed at least eight years of schooling, or possess a work record that indicates an absence of mental impairment.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AGB101 or placebo once daily for 78 weeks

78 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • AGB101
Trial Overview The trial tests AGB101 (220 mg daily) against a placebo to see if it slows down cognitive decline in Alzheimer's patients over 78 weeks. It measures the reduction in neuronal injury and assesses clinical progression using dementia rating scales.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AGB101 220 mg tabletExperimental Treatment1 Intervention
Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks.
Group II: Placebo Oral TabletPlacebo Group1 Intervention
Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks

AGB101 is already approved in United States, European Union, Canada, China for the following indications:

🇺🇸
Approved in United States as Levetiracetam for:
  • Partial onset seizures
  • Myoclonic seizures
  • Tonic-clonic seizures
🇪🇺
Approved in European Union as Levetiracetam for:
  • Epilepsy
  • Partial onset seizures
  • Myoclonic seizures
  • Tonic-clonic seizures
🇨🇦
Approved in Canada as Levetiracetam for:
  • Partial onset seizures
  • Myoclonic seizures
  • Tonic-clonic seizures
🇨🇳
Approved in China as Levetiracetam for:
  • Epilepsy
  • Partial onset seizures
  • Myoclonic seizures
  • Tonic-clonic seizures

Find a Clinic Near You

Who Is Running the Clinical Trial?

AgeneBio

Lead Sponsor

Trials
3
Recruited
250+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

Levetiracetam (LEV) has been shown to reduce reactive gliosis and the expression of the interleukin-1 beta (IL-1 beta) system in the hippocampus and piriform cortex of chronic epileptic rats, suggesting an anti-inflammatory effect in the brain during epilepsy.
In contrast to valproic acid, LEV specifically targets the IL-1 beta system, indicating a unique mechanism of action that may contribute to its efficacy in treating seizures.
Levetiracetam inhibits interleukin-1 beta inflammatory responses in the hippocampus and piriform cortex of epileptic rats.Kim, JE., Choi, HC., Song, HK., et al.[2018]
Hippocampal hyperactivity is linked to age-related cognitive decline and may play a significant role in the progression of late-onset Alzheimer's disease (LOAD), highlighting it as a potential therapeutic target.
Initial studies suggest that the antiepileptic drug levetiracetam can reduce this hyperactivity, potentially improving cognitive function and slowing the accumulation of pathology associated with LOAD.
Targeting Neural Hyperactivity as a Treatment to Stem Progression of Late-Onset Alzheimer's Disease.Haberman, RP., Branch, A., Gallagher, M.[2019]
Levetiracetam (LEV) did not negatively affect cognitive function in normal and amygdala-kindled rats, unlike traditional antiepileptic drugs such as sodium valproate (VPA), which impaired learning performance.
LEV also showed no impact on long-term potentiation (LTP) in hippocampal slices, suggesting it may be a safer option for cognitive function in epileptic patients compared to other AEDs.
Absence of negative impact of levetiracetam on cognitive function and memory in normal and amygdala-kindled rats.Lamberty, Y., Margineanu, DG., Klitgaard, H.[2010]

References

Levetiracetam inhibits interleukin-1 beta inflammatory responses in the hippocampus and piriform cortex of epileptic rats. [2018]
Targeting Neural Hyperactivity as a Treatment to Stem Progression of Late-Onset Alzheimer's Disease. [2019]
Absence of negative impact of levetiracetam on cognitive function and memory in normal and amygdala-kindled rats. [2010]
4.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Levetiracetam might act as an efficacious drug to attenuate cognitive deficits of Alzheimer's disease. [2019]
Levetiracetam monotherapy in Alzheimer patients with late-onset seizures: a prospective observational study. [2022]
A systematic review of the safety profile of levetiracetam: a new antiepileptic drug. [2022]
Spotlight on levetiracetam in epilepsy. [2021]
Dose-response effect of levetiracetam 1000 and 2000 mg/day in partial epilepsy. [2022]
An open-label study of levetiracetam at individualised doses between 1000 and 3000 mg day(-1) in adult patients with refractory epilepsy. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Reduction of hippocampal hyperactivity improves cognition in amnestic mild cognitive impairment. [2022]
Evaluation of levetiracetam effects on pilocarpine-induced seizures: cholinergic muscarinic system involvement. [2018]
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