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Find more clinical trials

AGB101 for Mild Cognitive Impairment Due to Alzheimer's Disease

Start: January 15, 2019
End: November 2022
Enrollment: 164

What Is This Study About?

This Phase 3 clinical trial will evaluate if AGB101 can slow the decline of cognition and function in people with mild cognitive impairment due to Alzheimer's. AGB101 is a low-dose preparation of levetiracetam, an anti-convulsant medication originally developed for the treatment of epilepsy. Participants will be randomly assigned to receive either a tablet of AGB101 or placebo, once a day for 78 weeks. Researchers will measure changes in cognition, function, and clinical progression of disease.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 85 Years

Must have:

  • In good general health
  • Have eighth-grade education or good work history sufficient to exclude mental retardation
  • Have good vision and hearing
  • Proficient fluency of the native local language
  • Study partner who has sufficient contact with the participant to be able to provide assessment of memory changes, who can accompany the participant to all the clinic visits for the duration of each visit, and who is able to provide an independent evaluation of the participant's functioning
  • Mild cognitive impairment due to Alzheimer's disease:
    • Mini-Mental State Examination scores of 24 to 30
    • A memory complaint reported by the participant or the study partner
    • Evidence of lower memory performance based on delayed recall in the International Shopping List Test
    • A clinical dementia rating score of 0.5 with a memory box score of 0.5 5
    • Essentially preserved activities of daily living
    • Cognitive decline not primarily caused by vascular, traumatic, or medical problems
  • If taking medications with potential pro-cognitive effects, such as cholinesterase inhibitors and memantine, on a stable dose for the past 3 months
  • If taking estrogen replacement therapy, Ginkgo biloba, or vitamin E, on a stable dose for the past 4 weeks
  • If taking other psychotropics, such as antidepressants or antipsychotics, on a stable dose for the past 3 months
  • Positron Emission Tomography (PET) scan with florbetaben (an 18F isotope diagnostic agent) consistent with the presence of amyloid plaques or documented evidence of an amyloid positive PET scan
  • Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of amnestic mild cognitive impairment due to Alzheimer's disease and with no clinically significant findings of non-Alzheimer's pathology that could account for the observed cognitive impairment
  • Willingness to undergo multiple MRIs
  • Willingness to allow collection of blood for apolipoprotein E (ApoE) genotyping

Must NOT have:

  • Use of anticonvulsant medications or excluded psychotropic medications within the past 3 months
  • Participation in a therapeutic clinical study for any medical or psychiatric indications within the past 3 months (6 months for biologics)
  • History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam)
  • Severe renal impairment (creatinine clearance of less than 30 mL/minute) or undergoing hemodialysis
  • Any significant neurological disease other than suspected incipient Alzheimer's disease, 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
    • History of significant head trauma followed by persistent neurologic deficits
    • 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
  • Diagnosis of major depression or bipolar disorder within the past 3 years
  • Psychotic features, agitation, or behavioral problems within the past 3 months
  • Modified Hachinski Ischemic Scale (HIS) score greater than 4
  • History of schizophrenia
  • History of alcohol or substance abuse or dependence within the past 3 years
  • Any significant systemic illness or unstable medical condition
  • Clinically significant abnormalities in B12 or thyroid function test
  • 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 and have a caregiver who can be a study partner)
  • Participation in clinical studies using the ISLT, Behavioral Pattern Separation (BPS-O) task, or the trail making test (A, B) within the past month
  • Female subjects must not be pregnant, lactating, or of childbearing potential (i.e., they must be 2 years post menopause or surgically sterile)

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: AgeneBio

Collaborator Sponsor

  • National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT03486938

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health