Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02094729
Other study ID # BAN2401-J081-104
Secondary ID
Status Completed
Phase Phase 1
First received January 9, 2014
Last updated June 4, 2015
Start date September 2013
Est. completion date May 2015

Study information

Verified date June 2015
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date May 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria

MCI due to AD

1. Subjects who have clinical and cognitive symptoms consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) core criteria for MCI

2. Subjects who have a Clinical Dementia Rating (CDR) of 0.5 and a memory box score of 0.5 or greater at Screening

3. 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

4. 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

- 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

5. Subjects who meet the NIA-AA core clinical criteria for probable AD

6. 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

7. Male or female subjects aged between 50 and 90 years, inclusive, at obtaining informed consent

8. 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

9. Body Mass Index (BMI) less than 35 kg/m2 at Screening

10. Females must not be pregnant or lactating, and specified contraceptive precautions must be followed

11. Subjects must have identified caregivers/informants

12. 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.

13. Provide voluntary written informed consent (obtaining as much as possible from subjects, but mandatory from their legal guardians).

14. Willing and able to comply with all aspects of the protocol.

Exclusion Criteria

1. Any neurological condition that may affect cognitive impairment

2. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening

3. Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject

4. 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)

5. Evidence of infection, tumor, stroke or other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening

6. 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

7. A prolonged QT interval (QTcF greater than or equal to 450 ms) as demonstrated by a repeated ECG at Screening

8. 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

9. Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
BAN2401 2.5 mg/kg
Cohorts 1: Intravenous infusions of 2.5 mg/kg BAN2401 for 60 +/- 10 minutes.
BAN2401 5 mg/kg
Cohorts 2: Intravenous infusions of 5 mg/kg BAN2401 for 60 +/- 10 minutes.
BAN2401 10 mg/kg
Cohorts 3: Intravenous infusions of 10 mg/kg BAN2401 for 60 +/- 10 minutes
Placebo
Intravenous infusions of placebo for 60 +/- 10 minutes.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 14 weeks Yes
Secondary Pharmacokinetics of BAN2401: Maximum Concentration (Cmax) Cmax after single and repeated administrations based on non-compartmental analysis. Up to 14 weeks No
Secondary Pharmacokinetics of BAN2401: time attain to Cmax (tmax) tmax after single and repeated administrations based on non-compartmental analysis. Up to 14 weeks No
Secondary Pharmacokinetics of BAN2401: Area under the curve (AUC) AUC after single and repeated administrations based on non-compartmental analysis. Up to 14 weeks No
Secondary Pharmacokinetics of BAN2401: Drug Clearance (CL) CL after single and repeated administrations based on non-compartmental analysis. Up to 14 weeks No
Secondary Pharmacokinetics of BAN2401: apparent volume of distribution at steady state (Vss) Vss after single and repeated administrations based on non-compartmental analysis. Up to 14 weeks No
Secondary 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. Up to 14 weeks No
Secondary Investigation of the effect of apolipoprotein allele4 (ApoE4) on the safety, tolerability and pharmacodynamic (PD) response of repeated intravenous infusions of BAN2401 Up to 14 weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT05040048 - Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
Withdrawn NCT03316898 - A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's Disease Phase 1
Withdrawn NCT02860065 - CPC-201 Alzheimer's Disease Type Dementia: PET Study Phase 2
Completed NCT01315639 - New Biomarker for Alzheimer's Disease Diagnostic N/A
Not yet recruiting NCT03740178 - Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005) Phase 1
Recruiting NCT05607615 - A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease Phase 2
Terminated NCT03307993 - Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease Phase 1
Recruiting NCT02912936 - A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease N/A
Active, not recruiting NCT02899091 - Evaluation of the Safety and Potential Therapeutic Effects of CB-AC-02 in Patients With Alzheimer's Disease Phase 1/Phase 2
Not yet recruiting NCT02868905 - Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women N/A
Completed NCT02907567 - Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease Phase 1/Phase 2
Completed NCT02516046 - 18F-AV-1451 Autopsy Study Phase 3
Terminated NCT02521558 - Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease N/A
Completed NCT02580305 - SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study Phase 2
Recruiting NCT02247180 - Cognitive Rehabilitation in Alzheimer`s Disease N/A
Completed NCT02317523 - Alzheimer's Caregiver Coping: Mental and Physical Health N/A
Terminated NCT02220738 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors Phase 1
Completed NCT02260167 - Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol N/A
Completed NCT02256306 - The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study N/A
Completed NCT01922258 - Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Phase 3