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Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease (Hope4MCI)

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ClinicalTrials.gov Identifier: NCT03486938
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
AgeneBio

Brief 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).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Prodromal Alzheimer's Disease Drug: Placebo Oral Tablet Drug: AGB101 220 mg tablet Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of AGB101on Slowing Progression of Mild Cognitive Impairment Due to Alzheimer's Disease
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Oral Tablet
Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks.
Drug: Placebo Oral Tablet
Placebo oral tablet

Experimental: AGB101 220 mg tablet
Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks.
Drug: AGB101 220 mg tablet
220 mg AGB101 active compound




Primary Outcome Measures :
  1. CDR-SB [ Time Frame: 78 weeks ]
    Change in CDR-SB score from baseline


Secondary Outcome Measures :
  1. MMSE [ Time Frame: 78 weeks ]
    Change in MMSE score from baseline

  2. FAQ [ Time Frame: 78 weeks ]
    Change in FAQ score from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects between 55 and 85 years old (inclusive) in good general health:

    1. Willing and able to consent and participate for the duration of the study
    2. Have eighth-grade education or good work history sufficient to exclude mental retardation
    3. Have visual and auditory acuity adequate for neuropsychological testing
    4. Have proficient fluency of the native local language to participate in all the neuropsychological test assessments
  2. 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
  3. 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:

    1. MMSE scores between 24 and 30 (inclusive; exceptions may be made for subjects with <8 years of education at the discretion of the sponsor)
    2. A memory complaint reported by the subject or his/her study partner
    3. Evidence of lower memory performance based on delayed recall in the International Shopping List Test (ISLT)
    4. A clinical dementia rating (CDR) score of 0.5 with a memory box score of ≥0.5
    5. Essentially preserved activities of daily living
    6. Cognitive decline not primarily caused by vascular, traumatic, or medical problems (alternative causes of cognitive decline are ruled out)
  4. Permitted medications:

    1. With potential pro-cognitive effects, such as cholinesterase inhibitors and memantine, must be at a stable dose for ≥3 months prior to screening and remain stable throughout the study; estrogen replacement therapy, Ginkgo biloba, and vitamin E must be at a stable dose for ≥4 weeks prior to screening and remain stable throughout the study
    2. Other psychotropics, such as antidepressants and antipsychotics, must be at a stable dose for ≥3 months prior to screening and remain stable throughout the study
  5. Willing and able to undergo imaging procedures:

    1. A Positron Emission Tomography (PET) scan with Florbetaben(an 18F isotope diagnostic agent) or documented evidence of an amyloid positive PET scan.

      The Florbetaben scan performed at baseline must be read by a qualified physician with experience in reading amyloid PET scans, and it should be consistent with the presence of amyloid plaques.

    2. Repeated MRI scans (3 Tesla) with no contraindications to MRI. MRI scan results are consistent with the diagnosis of amnestic MCI due to Alzheimer's disease with no clinically significant findings of non-AD pathology that could account for the observed cognitive impairment.
  6. Willing to allow collection of blood for apolipoprotein E (ApoE) genotyping.

Exclusion Criteria:

  1. Use of anticonvulsant medications or excluded psychotropic medications within 3 months prior to the baseline visit
  2. Participation in a therapeutic clinical study for any medical or psychiatric indications within 3 months (6 months for biologics) of the screening visit, or at any time during the study.

    Subjects must understand that they may only enroll in this clinical study once; they may not enroll in any other clinical study while participating in the current study, and they may not participate in a clinical study of a drug, biologic, therapeutic device, or medical food, in which the last dose/administration was received within 3 months (6 months for biologics) prior to screening.

  3. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam)
  4. Severe renal impairment (creatinine clearance of <30 mL/minute) or undergoing hemodialysis
  5. Any significant neurological disease other than suspected incipient AD, 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, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities
  6. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
  7. Diagnosis of major depression or bipolar disorder, as described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed (DSM-5), within the past 3 years.

    Psychotic features, agitation, or behavioral problems within the last 3 months that could lead to difficulty complying with the protocol. Subjects must not have a major depressive disorder or other types of depression that could confound diagnosis of MCI due to AD, or clinical assessments, in the opinion of the investigator. The geriatric depression scale (long form score >9 suggests depression) results should be reviewed by the investigator to assist in this determination.

  8. Modified Hachinski Ischemic Scale (HIS) score >4
  9. History of schizophrenia (DSM-5 criteria)
  10. History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria)
  11. Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements.
  12. 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.

  13. 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.
  14. Any use of excluded medications (e.g., antiepileptics, certain antidepressants or antipsychotics, antihistamines with anticholinergic properties, opiates)
  15. 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
  16. Female subjects must not be pregnant, lactating, or of childbearing potential (i.e., they must be 2 years post menopause or surgically sterile)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486938


Contacts
Contact: Clinical Development (610) 964-2000 clinical@agenebio.com

Locations
United States, Florida
University of South Florida Psychiatry and Behavioral Neurosciences Recruiting
Tampa, Florida, United States, 33613
Contact: Jean Fils    813-974-2832    jfils@health.usf.edu   
Contact: Julie Samson    813-974-7006    jsamson@health.usf.edu   
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Marilyn Albert    410-614-3040    malbert9@jhmi.edu   
Contact: Carrie Speck    410-955-5057    cspeck1@jhmi.edu   
United States, New York
Neurological Associates of Albany PC Recruiting
Albany, New York, United States, 12208
Contact: Richard Holub    518-426-0575    rholub@naaresearch.com   
Contact: Jillian Ela    518-426-0575    Research@naaresearch.com   
Sponsors and Collaborators
AgeneBio
National Institute on Aging (NIA)
Investigators
Principal Investigator: Richard Mohs, PhD AgeneBio
Study Director: Sharon Rosenzweig-Lipson, PhD AgeneBio

Responsible Party: AgeneBio
ClinicalTrials.gov Identifier: NCT03486938     History of Changes
Other Study ID Numbers: AGB101 MCD
R56AG055416 ( U.S. NIH Grant/Contract )
R01AG048349 ( U.S. NIH Grant/Contract )
R01AG061091 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders