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AGB101 for Mild Cognitive Impairment Due to Alzheimer's Disease

Recruiting

This Phase III clinical trial will evaluate whether AGB101 slows cognitive and functional impairment in people with prodromal Alzheimer's disease (mild cognitive impairment due to Alzheimer's).

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years All No
January 15, 2019
December 2022
830

  • 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

  • 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)

AGB101 is a low-dose formulation of levetiracetam, an atypical anti-convulsant medication originally developed for the treatment of epilepsy. Participants will be randomized to receive a tablet of AGB101 or placebo, orally once a day once for 78 weeks. Participants will be assessed for cognitive and functional changes and clinical progression of disease.

Name City State Zip Status Primary Contact
Banner Alzheimer's Institute
Phoenix Arizona 85006 Recruiting Po-Heng Tsai
602-839-6900
po-heng.tsai@bannerhealth.com
Senior Clinical Trials, Inc.
Laguna Hills California 92653 Recruiting Robert Feldman
949-588-0909
rgfeldman@cox.net
Excell Research Inc
Oceanside California 92056 Recruiting Sherry Soefje
760-758-2222
soefjemd@excellresearch.com
The Mile High Research Center
Denver Colorado 80218 Recruiting Jack Klapper
303-839-9900
jkheaddoc@gmail.com
Boynton Beach Medical Research Institite
Boynton Beach Florida 33437 Recruiting Gabriella Gerstle, MD
561-572-3220
ggerstle@gminstitutes.com
Brain Matters Research
Delray Beach Florida 33445 Recruiting Mark Brody
561-374-8461
mbrody@ergclinical.com
MD Clinical
Hallandale Beach Florida 33009 Recruiting Beth Safirstein, MD
305-762-1426
bsafirstein@mdclinical.org
Miami Jewish Health
Miami Florida 33137 Recruiting Marc Agronin
305-762-1426
magronin@miamijewishhealth.org
Bioclinica Research
Orlando Florida 32806 Recruiting Ira Goodman
407-426-9299
ira.goodman@bioclinica.com
IMIC Research
Palmetto Bay Florida 33157 Recruiting Evelyn Lopez-Brignoni
305-252-2199
Evelyn@aktamedika.com
The Roskamp Institute, Inc
Sarasota Florida 34243 Recruiting Andrew Keegan
941-256-8018
akeegan@roskampinstitute.org
Brain Matters Research
Stuart Florida 34997 Recruiting Mark Brody, MD
772-223-7880
mbrody@ergclinical.com
University of South Florida Psychiatry and Behavioral Neurosciences
Tampa Florida 33613 Withdrawn

NeuroStudies.net, LLC
Decatur Georgia 30033 Recruiting Marshall Nash
404-475-0552
mnash@neurostudies.net
Great Lakes Clinical Trials
Chicago Illinois 60640 Recruiting Jeffrey Ross
773-275-3501
jross@greatlakesclinicaltrials.com
Johns Hopkins University School of Medicine
Baltimore Maryland 21205 Recruiting Marilyn Albert
410-614-3040
malbert9@jhmi.edu
Memory Center/Hattiesburg Clinic
Hattiesburg Mississippi 39401 Recruiting Ronald Schwatz, MD
601-268-5620
Ronald.schwartz@hattiesburgclinic.com
Clinical Research Professionals
Chesterfield Missouri 63005 Recruiting Siddharth Kaul, MD
636-220-1200
skaul@clinicalresearchprofessionals.net
The NeuroCognitive Institute
Mount Arlington New Jersey 07856 Recruiting Gerald Tramontano, MD
973-601-0100
geraldt@neuroci.com
Global Medical Institutes LLC; Princeton Medical Institute
Princeton New Jersey 08540 Recruiting Jeffrey Apter
609-921-3555
Japter@gminstitutes.com
Neurology Specialist of Monmouth County, PA
West Long Branch New Jersey 07764 Recruiting Noah Gilson
732-935-1857
ngmdresearch@gmail.com
Neurological Associates of Albany PC
Albany New York 12208 Recruiting Richard Holub
518-426-0575
rholub@naaresearch.com
Richmond Behavioral Associates
Staten Island New York 10312 Recruiting Mark DiBuono
718-317-5522
Dibuono@rbany.com
Clinical Biotechnology Research Institute at RSFH
Charleston South Carolina 29401 Recruiting Olga Brawman-Mintzer, MD
843-724-2220
olga.mintzer@rsfh.com
Clinical Trials of Texas, Inc
San Antonio Texas 78229 Recruiting Jason Miller
210-949-0122
jmillerdo@cttexas.com
Toronto Memory Program
Toronto Ontario M3B 2S7 Recruiting Sharon Cohen
416-386-9761
cohen@memorydisorders.ca

AgeneBio

  • National Institute on Aging (NIA)

Name Role Affiliation
Richard Mohs, PhD Principal Investigator AgeneBio
Sharon Rosenzweig-Lipson, PhD Study Director AgeneBio

Name Phone Email
Clinical Development 610-964-2000 clinical@agenebio.com

NCT03486938

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of AGB101 on Slowing Progression of Mild Cognitive Impairment Due to Alzheimer's Disease