Mild Cognitive ImpairmentPhase 2/3HOPE4MCINCT03486938

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

A Phase 2/3 study testing AGB101 220 mg tablet in people with Mild Cognitive Impairment and Prodromal Alzheimer's Disease, run by AgeneBio at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 55 to 85 years
Conditions the study is for: Mild Cognitive Impairment, Prodromal Alzheimer's Disease
What is being tested?: AGB101 220 mg tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 164 participants
Where: 24 sitesin 2 countries
Study dates: 13 Dec 2018to 2 Nov 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects between 55 and 85 years old (inclusive) in good general health:
Willing and able to consent and participate for the duration of the study
Have eighth-grade education or good work history sufficient to exclude mental retardation
Have visual and auditory acuity adequate for neuropsychological testing
Have proficient fluency of the native local language to participate in all the neuropsychological test assessments
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

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

Who cannot join

Use of anticonvulsant medications or excluded psychotropic medications within 3 months prior to the baseline visit
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.
History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam)
Severe renal impairment (creatinine clearance of <30 mL/minute) or undergoing hemodialysis
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

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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, 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.
Modified Hachinski Ischemic Scale (HIS) score >4
History of schizophrenia (DSM-5 criteria)
History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria)
Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements.
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.
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.
Any use of excluded medications (e.g., antiepileptics, certain antidepressants or antipsychotics, antihistamines with anticholinergic properties, opiates)
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
Female subjects must not be pregnant, lactating, or of childbearing potential (i.e., they must be 2 years post menopause or surgically sterile)

Trial locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

United States23 sites

Neurological Associates of Albany PC
Albany, New York, 12208
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Boynton Beach Medical Research Institite
Boynton Beach, Florida, 33437
Clinical Biotechnology Research Institute at RSFH
Charleston, South Carolina, 29401
Clinical Research Professionals
Chesterfield, Missouri, 63005
Great Lakes Clinical Trials
Chicago, Illinois, 60640
NeuroStudies.net, LLC
Decatur, Georgia, 30033
Brain Matters Research
Delray Beach, Florida, 33445
The Mile High Research Center
Denver, Colorado, 80218
MD Clinical
Hallandale, Florida, 33009
Memory Center/Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Senior Clinical Trials, Inc.
Laguna Hills, California, 92653
Miami Jewish Health
Miami, Florida, 33137
The NeuroCognitive Institute
Mount Arlington, New Jersey, 07856
Excell Research Inc
Oceanside, California, 92056
Bioclinica Research
Orlando, Florida, 32806
IMIC Research
Palmetto Bay, Florida, 33157
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Global Medical Institutes LLC; Princeton Medical Institute
Princeton, New Jersey, 08540
The Roskamp Institute, Inc
Sarasota, Florida, 34243
Richmond Behavioral Associates
Staten Island, New York, 10312
Brain Matters Research
Stuart, Florida, 34997
Neurology Specialist of Monmouth County, PA
West Long Branch, New Jersey, 07764

Other trials in United States

Canada1 site

Toronto Memory Program
Toronto, Ontario, M3B 2S7

Other trials in Canada

About this study

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

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).

Conditions: Mild Cognitive Impairment, Prodromal Alzheimer's Disease
Being tested: Placebo Oral Tablet, AGB101 220 mg tablet
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo Oral TabletDrug
Placebo oral tablet
AGB101 220 mg tabletDrug
220 mg AGB101 active compound

Study groups in NCT03486938
Study group	Role	What they receive
Placebo Oral Tablet	Placebo comparator	Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks. Receives: Drug: Placebo Oral Tablet
AGB101 220 mg tablet	Experimental	Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks. Receives: Drug: AGB101 220 mg tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score From Baseline
CDR-SB scores at baseline were subtracted from CDR-SB scores at week 78 to generate the change score from baseline, with a possible total range of -18 to 18. Positive change scores reflect greater impairment on the CDR-SB at week 78, while negative change scores reflect less impairment on the CDR-SB at week 78.
Measured: 78 weeks

Secondary outcomes (2)

Change in Mini Mental Status Exam (MMSE) Score From Baseline
MMSE scores at baseline were subtracted from MMSE scores at week 78 to generate the change score from baseline, with a possible total range of -30 to 30. Positive change scores reflect improved performance on the MMSE at week 78, while negative change scores reflect worsening performance on the MMSE at week 78.
Measured: 78 weeks
Change in Functional Activities Questionnaire (FAQ) Score From Baseline
FAQ scores at baseline were subtracted from FAQ scores at week 78 to generate the change score from baseline, with a possible total range of -30 to 30. Positive change scores reflect greater impairment on the FAQ at week 78, while negative change scores reflect less impairment on the FAQ at week 78.
Measured: 78 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 20182 Nov 2022

First posted3 Apr 2018
Study start13 Dec 2018
Primary completion2 Nov 2022
Study completion2 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03486938
Sponsor's protocol ID: AGB101 MCD
Other IDs: R56AG055416, R01AG048349, R01AG061091
Acronym: HOPE4MCI
Status last verified: May 2024
First submitted: 28 Mar 2018
Last updated: 17 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03486938
Acronym / sponsor ID: HOPE4MCI / AGB101 MCD
Conditions: Mild Cognitive Impairment, Prodromal Alzheimer's Disease
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: AgeneBioIndustry (pharma, biotech, devices)
Collaborators: National Institute on Aging (NIA)
Study start: 13 Dec 2018 (actual)
Primary completion: 2 Nov 2022 (actual)
Study completion: 2 Nov 2022 (actual)
First posted: 3 Apr 2018 (actual)
Results: Posted 17 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo Oral Tablet	Placebo comparator	Drug: Placebo Oral TabletMatching placebo to AGB101 tablet once daily, taken orally, for 78 weeks.
AGB101 220 mg tablet	Experimental	Drug: AGB101 220 mg tabletSingle 220 mg AGB101 tablet once daily, taken orally, for 78 weeks.

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Subjects between 55 and 85 years old (inclusive) in good general health:
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
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:
Permitted medications:
Willing and able to undergo imaging procedures:

Key exclusion criteria (19 listed)

Use of anticonvulsant medications or excluded psychotropic medications within 3 months prior to the baseline visit
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.
History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam)
Severe renal impairment (creatinine clearance of <30 mL/minute) or undergoing hemodialysis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo Oral TabletPlacebo oral tablet	Drug	Placebo Oral Tablet
AGB101 220 mg tablet220 mg AGB101 active compound	Drug	AGB101 220 mg tablet

Primary outcome

Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score From Baseline
Time frame: 78 weeks
CDR-SB scores at baseline were subtracted from CDR-SB scores at week 78 to generate the change score from baseline, with a possible total range of -18 to 18. Positive change scores reflect greater impairment on the CDR-SB at week 78, while negative change scores reflect less impairment on the CDR-SB at week 78.

2 secondary outcomes

Change in Mini Mental Status Exam (MMSE) Score From Baseline
Time frame: 78 weeks
Change in Functional Activities Questionnaire (FAQ) Score From Baseline
Time frame: 78 weeks

Results and safety

Results posted to the registry on 17 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Oral Tablet	83	66
AGB101 220 mg Tablet	81	55

Primary outcome: Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score From Baseline

Time frame: 78 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo Oral Tablet n = 83	AGB101 220 mg Tablet n = 81
Value	1.1 (2)	.9 (1.5)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Oral Tablet	10 of 83 (12%)	49 of 83 (59%)	0 of 83
AGB101 220 mg Tablet	13 of 78 (16.7%)	40 of 78 (51.3%)	2 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Mohs, PhD principal investigator

AgeneBio

Sharon Rosenzweig-Lipson, PhD study director

AgeneBio

Russell Barton, MS study director

AgeneBio

24 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AGB101 220 mg tablet in people with Mild Cognitive Impairment and Prodromal Alzheimer's Disease, run by AgeneBio at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score From Baseline (time frame: 78 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03486938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.