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Alzheimer's DiseasePhase 1NCT02094729

A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamic Response of Repeated Intravenous Infusions of BAN2401 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

A Phase 1 study testing BAN2401 2.5 mg/kg, BAN2401 5 mg/kg and BAN2401 10 mg/kg in people with Alzheimer's Disease, run by Eisai Co., Ltd. at 4 sites in Japan.

Completed

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

Official record
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Trial summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild Alzheimer's disease. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
BAN2401 2.5 mg/kg, BAN2401 5 mg/kg and BAN2401 10 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
4 sitesJapan
Study dates
Sep 2013to May 2015
Phase
Phase 1
Are there results?
None posted in the registry

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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • MCI due to AD
  • Subjects who have clinical and cognitive symptoms consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) core criteria for MCI
  • Subjects who have a Clinical Dementia Rating (CDR) of 0.5 and a memory box score of 0.5 or greater at Screening
  • Subjects who report a history of subjective memory decline with slow progression at least 1 year before Screening, or subjects whose information provider or attending physician reports a history of memory decline with slow progression at least 1 year before Screening
  • Subjects with objective impairment in episodic memory as indicated by 1-1.5 standard deviations below age-adjusted mean in the Wechsler Memory Scale-Revised (WMS-R) logical memory II (delayed recall) at Screening:
  • less than or equal to 15 for age 50 to 64 years
Show all 22Show fewer
  • less than or equal to 12 for age 65 to 69 years
  • less than or equal to 11 for age 70 to 74 years
  • less than or equal to 9 for age 75 to 79 years
  • less than or equal to 7 for age 80 to 90 years
  • Mild AD
  • Subjects who meet the NIA-AA core clinical criteria for probable AD
  • Subjects who have a CDR of 0.5 or 1.0 and a memory box score of 0.5 or greater at Screening
  • All subjects
  • Male or female subjects aged between 50 and 90 years, inclusive, at obtaining informed consent
  • Subjects who have an Mini Mental State Examination (MMSE) score greater than or equal to 22 and less than or equal to 30 at Screening
  • Body Mass Index (BMI) less than 35 kg/m2 at Screening
  • Females must not be pregnant or lactating, and specified contraceptive precautions must be followed
  • Subjects must have identified caregivers/informants
  • Must have an informant or a caregiver who will provide written informed consent voluntarily and is able to spend 3 days a week with the subject (4 hours per day), and is able to support the subject during the study period by providing necessary patient information, assisting treatment compliance, and accompanying the subject to all scheduled visits (if needed) throughout the study.
  • Provide voluntary written informed consent (obtaining as much as possible from subjects, but mandatory from their legal guardians).
  • Willing and able to comply with all aspects of the protocol.

Who cannot join

  • Any neurological condition that may affect cognitive impairment
  • History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
  • Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject
  • Any medical devices contraindicated for MRI scanning (e.g., cardiac pacemaker/defibrillator, ferromagnetic metal implants, any devices other than those approved as safe for use in MRI scanners)
  • Evidence of infection, tumor, stroke or other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening
  • Evidence of other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening, or other significant pathological findings on brain MRI at Screening
Show all 9Show fewer
  • A prolonged QT interval (QTcF greater than or equal to 450 ms) as demonstrated by a repeated ECG at Screening
  • Any other clinically significant conditions (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments
  • Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Study site

    Kobe, Hyōgo

  • Study site

    Koto-ku, Tokyo

  • Study site

    Kurashiki, Okayama-ken

  • Study site

    Sendai, Miyagi

Other trials in Japan

About this study

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild Alzheimer's disease.

Read the detailed description

This is a multicenter, randomized, placebo-controlled, double-blind, multiple ascending dose study in a total of 24 subjects (8 subjects per cohort) with MCI due to AD and mild AD. The study consists of three cohorts to evaluate the safety, tolerability and PK of BAN2401 at three dose levels (2.5, 5, and 10 mg/kg). Each cohort consists of Screening Period before randomization, Treatment Period from randomization to last dose, and Follow-up Period after last dose. Cohorts 1, 2, and 3 will receive 2.5 mg/kg, 5 mg/kg, and 10 mg/kg of BAN2401, respectively.

Being tested
BAN2401 2.5 mg/kg, BAN2401 5 mg/kg, BAN2401 10 mg/kg, Placebo
Keywords
mild cognitive impairment, Alzheimer's disease
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

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

  • BAN2401 2.5 mg/kgDrug

    Cohorts 1: Intravenous infusions of 2.5 mg/kg BAN2401 for 60 +/- 10 minutes.

  • BAN2401 5 mg/kgDrug

    Cohorts 2: Intravenous infusions of 5 mg/kg BAN2401 for 60 +/- 10 minutes.

  • BAN2401 10 mg/kgDrug

    Cohorts 3: Intravenous infusions of 10 mg/kg BAN2401 for 60 +/- 10 minutes

  • PlaceboDrug

    Intravenous infusions of placebo for 60 +/- 10 minutes.

Study groups in NCT02094729
Study groupRoleWhat they receive
BAN2401 2.5 mg/kgExperimentalCohorts 1: Intravenous infusions of 2.5 mg/kg BAN2401
Receives: Drug: BAN2401 2.5 mg/kg
BAN2401 5 mg/kgExperimentalCohorts 2: Intravenous infusions of 5 mg/kg BAN2401
Receives: Drug: BAN2401 5 mg/kg
BAN2401 10 mg/kgExperimentalCohorts 3: Intravenous infusions of 10 mg/kg BAN2401
Receives: Drug: BAN2401 10 mg/kg
PlaceboPlacebo comparatorIntravenous infusions of placebo for 60 +/- 10 minutes.
Receives: Drug: Placebo

What is being measured

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

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs; laboratory parameters (hematology, blood chemistry, and urinalysis); vital signs; electrocardiograms; and physical examination; as well as a risk of suicide using C-SSRS and brain MRI.

    Measured: Up to 14 weeks

Secondary outcomes (7)

  1. Pharmacokinetics of BAN2401: Maximum Concentration (Cmax)

    Cmax after single and repeated administrations based on non-compartmental analysis.

    Measured: Up to 14 weeks

  2. Pharmacokinetics of BAN2401: time attain to Cmax (tmax)

    tmax after single and repeated administrations based on non-compartmental analysis.

    Measured: Up to 14 weeks

  3. Pharmacokinetics of BAN2401: Area under the curve (AUC)

    AUC after single and repeated administrations based on non-compartmental analysis.

    Measured: Up to 14 weeks

  4. Pharmacokinetics of BAN2401: Drug Clearance (CL)

    CL after single and repeated administrations based on non-compartmental analysis.

    Measured: Up to 14 weeks

  5. Pharmacokinetics of BAN2401: apparent volume of distribution at steady state (Vss)

    Vss after single and repeated administrations based on non-compartmental analysis.

    Measured: Up to 14 weeks

  6. Investigation of the effect of repeated intravenous infusions of BAN2401 on the immunogenicity and CSF biomarkers

    Summary statistics (mean, standard deviation, median, minimum and maximum) will be calculated for each measurement of CSF concentrations of AB1-40, AB1-42, AB1-x, total tau and p-tau and their percent changes from baseline.

    Measured: Up to 14 weeks

  7. Investigation of the effect of apolipoprotein allele4 (ApoE4) on the safety, tolerability and pharmacodynamic (PD) response of repeated intravenous infusions of BAN2401

    Measured: Up to 14 weeks

Timeline

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

  1. First posted24 Mar 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionMar 2015
  4. Study completionMay 2015

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02094729
Sponsor's protocol ID
BAN2401-J081-104
Status last verified
Jun 2015
First submitted
9 Jan 2014
Last updated
8 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAN2401 2.5 mg/kg, BAN2401 5 mg/kg and BAN2401 10 mg/kg in people with Alzheimer's Disease, run by Eisai Co., Ltd. at 4 sites in Japan.

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 22 inclusion and 9 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Up to 14 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 NCT02094729.

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 8 Jun 2015.

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Clinical Trial NCT02094729 | AzTrials