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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03887455




Registration number
NCT03887455
Ethics application status
Date submitted
21/03/2019
Date registered
25/03/2019
Date last updated
23/11/2020

Titles & IDs
Public title
A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease
Scientific title
A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
Secondary ID [1] 0 0
2018-004739-58
Secondary ID [2] 0 0
BAN2401-G000-301
Universal Trial Number (UTN)
Trial acronym
Clarity AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lecanemab
Treatment: Drugs - Placebo

Experimental: Core Study: Lecanemab 10 mg/kg biweekly -

Placebo Comparator: Core Study: Placebo -

Experimental: Extension Phase: Lecanemab 10 mg/kg biweekly -


Treatment: Drugs: Lecanemab
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.

Treatment: Drugs: Placebo
Biweekly (once every 2 weeks) administered i.v. infusion.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Core Study: Change from Baseline in the CDR-SB at 18 Months
Timepoint [1] 0 0
Baseline, 18 months
Primary outcome [2] 0 0
Extension Phase: Number of Participants With Adverse Events (AEs), Clinically Significant Change From Baseline in Vital Signs Values, Abnormal MRI and ECG Values, Clinically Significant Findings in Laboratory Values, Positive ADAs, and any Suicidality - Here MRI means magnetic resonance imaging, ECG means electrocardiogram, and ADAs means antidrug antibodies.
Timepoint [2] 0 0
Month 18 up to Month 45
Primary outcome [3] 0 0
Extension Phase: Change from Core Study Baseline in CDR-SB
Timepoint [3] 0 0
Baseline up to Month 45
Secondary outcome [1] 0 0
Core Study: Change from Baseline in the Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) Composite at 18 Months
Timepoint [1] 0 0
Baseline, 18 months
Secondary outcome [2] 0 0
Core Study: Change from Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months
Timepoint [2] 0 0
Baseline, 18 months
Secondary outcome [3] 0 0
Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months
Timepoint [3] 0 0
Baseline, 18 months

Eligibility
Key inclusion criteria
Core Study: Inclusion Criteria

Diagnosis: Mild Cognitive Impairment (MCI) due to Alzheimer's disease - intermediate
likelihood:

- Meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical
criteria for MCI due to Alzheimer's disease - intermediate likelihood

- Have a global Clinical Dementia Rating (CDR) score of 0.5 and CDR Memory Box score of
0.5 or greater at Screening and Baseline

- Report a history of subjective memory decline with gradual onset and slow progression
over the last 1 year before Screening; must be corroborated by an informant

Mild Alzheimer's disease dementia:

- Meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia

- Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of 0.5 or greater at
Screening and Baseline

Key Inclusion Criteria that must be met by all participants:

- Objective impairment in episodic memory as indicated by at least 1 standard deviation
below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory (subscale) II
(WMS-IV LMII)

- Positive biomarker for brain amyloid pathology

- Male or female participants aged greater than or equal to (>=) 50 and less than or
equal to (<=) 90 years, at the time of informed consent

- Mini mental state examination (MMSE) score >=22 at Screening and Baseline and <=30 at
Screening and Baseline

- Body mass index (BMI) greater than (>)17 and less than (<) 35 at Screening

- If receiving an approved Alzheimer's disease treatment such as acetylcholinesterase
inhibitor (AChEIs) or memantine or both for Alzheimer's disease, must be on a stable
dose for at least 12 weeks prior to Baseline. Treatment-naive participants for
Alzheimer's disease can be entered into the study. Unless otherwise stated,
participants must have been on stable doses of all other (that is, non-Alzheimer's
disease-related) permitted concomitant medications for at least 4 weeks prior to
Baseline. Use of memantine will not be allowed for participants in Japan

- Have an identified study partner (defined as a person able to support the participant
for the duration of the study and who spends at least 8 hours per week with the
participant)

- Provide written informed consent. If a participant lacks capacity to consent in the
investigator's opinion, the participant's assent should be obtained, if required in
accordance with local laws, regulations and customs, plus the written informed consent
of a legal representative should be obtained (capacity to consent and definition of
legal representative should be determined in accordance with applicable local laws and
regulations). In countries where local laws, regulations, and customs do not permit
participants who lack capacity to consent to participate in this study (example,
Germany and Spain), they will not be enrolled

Extension Phase:

- Participants who have completed the Core Study

- Have a BMI >17 and <35

- Must continue to have a study partner who is willing and able to provide follow-up
information on the participant throughout the course of the Extension Phase

- Provide written informed consent for the Extension Phase. If a participant lacks
capacity to consent in the investigator's opinion, the participant's assent should be
obtained, if required and in accordance with local laws, regulations and customs, plus
the written informed consent of a legal representative should be obtained (capacity to
consent and definition of legal representative should be determined in accordance with
applicable local laws and regulations). In countries where local laws, regulations,
and customs do not permit participants who lack capacity to consent to participate in
this study (example, Germany and Spain), they will not be enrolled
Minimum age
50 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Any neurological condition that may be contributing to cognitive impairment above and
beyond that caused by the participant's Alzheimer's disease

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

- Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or
delusions) that could interfere with study procedures in the participant

- Geriatric Depression Scale (GDS) score >=8 at Screening

- Contraindications to MRI scanning, including cardiac pacemaker/defibrillator,
ferromagnetic metal implants (example in skull and cardiac devices other than those
approved as safe for use in MRI scanners)

- Evidence of other clinically significant lesions on brain MRI at Screening that could
indicate a dementia diagnosis other than Alzheimer's disease

- Other significant pathological findings on brain MRI at screening, including but not
limited to: more than 4 microhemorrhages (defined as 10 millimeter [mm] or less at the
greatest diameter); a single macrohemorrhage >10 mm at greatest diameter; an area of
superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion,
encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of
multiple lacunar infarcts or stroke involving a major vascular territory, severe small
vessel, or white matter disease; space occupying lesions; or brain tumors (however,
lesions diagnosed as meningiomas or arachnoid cysts and <1 centimeter [cm] at their
greatest diameter need not be exclusionary)

- Any immunological disease which is not adequately controlled, or which requires
treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of
monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the
study

- Participants with a bleeding disorder that is not under adequate control (including a
platelet count <50,000 or international normalized ratio [INR] >1.5 for participants
who are not on anticoagulant treatment, example, warfarin). Participants who are on
anticoagulant therapy should have their anticoagulant status optimized and be on a
stable dose for 4 weeks before Screening. Participants who are on anticoagulant
therapy are not permitted to participate in cerebrospinal fluid (CSF) assessments

- Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal
disease) which are not stably and adequately controlled, or which in the opinion of
the investigator(s) could affect the participant's safety or interfere with the study
assessments

- Participation in a clinical study involving any therapeutic monoclonal antibody,
protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine within
6 months before screening unless it can be documented that the participant was
randomized to placebo

- Participation in a clinical study involving any anti-amyloid therapies (including any
monoclonal antibody therapies and any ß-site amyloid precursor protein cleaving enzyme
[BACE] inhibitor therapies) unless it can be documented that the participant only
received placebo

- Participants who have any known prior exposure to lecanemab

- Participants who were dosed in a clinical study involving any new chemical entities
for Alzheimer's disease (AD) within 6 months prior to screening unless it can be
documented that the participant was in a placebo treatment arm

Extension Phase: Exclusion Criteria

- Participants who discontinued early from the Core Study

- Participants who develop the following conditions from the time of Screening for the
Core Study to the start of the Extension Phase

- TIA, stroke, or seizures

- Any neurological condition that may be contributing to cognitive impairment above
and beyond that caused by the participant's AD

- Any psychiatric diagnosis or symptoms, (example, hallucinations, major
depression, or delusions) that could interfere with study procedures in the
participant

- Contraindications to MRI scanning, including cardiac pacemaker/defibrillator,
ferromagnetic metal implants (example, in skull and cardiac devices other than
those approved as safe for use in MRI scanners)

- Other significant pathological findings on brain MRI during the Core Study
including but not limited to: cerebral contusion, encephalomalacia, aneurysms,
vascular malformations, or infective lesions; evidence of multiple lacunar
infarcts or stroke involving a major vascular territory, severe small vessel, or
white matter disease; space occupying lesions; or brain tumors (however, lesions
diagnosed as meningiomas or arachnoid cysts and <1 cm at their greatest diameter
need not be exclusionary

- Any immunological disease which is not adequately controlled, or which requires
treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of
monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the
study

- Any other medical conditions (example, cardiac, respiratory, gastrointestinal,
renal disease) which are not stably and adequately controlled, or which in the
opinion of the investigator(s) could affect the participant's safety or interfere
with the study assessments

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Translational Research Centre - Darlinghurst
Recruitment hospital [2] 0 0
NSW Neurodegenerative Clinical Trials (HammondCare) - Greenwich
Recruitment hospital [3] 0 0
KaRa Institute of Neurological Diseases - Macquarie Park
Recruitment hospital [4] 0 0
The Prince Charles Hospital/Internal Medicine & Dementia Research Unit - Chermside Brisbane
Recruitment hospital [5] 0 0
Central Adelaide Local Health Network, The Queen Elizabeth Hospital and the Royal Adelaide Hospital - Woodville South, Adelaid
Recruitment hospital [6] 0 0
Austin Health - Medical and Cognitive Research Unit - Ivanhoe
Recruitment hospital [7] 0 0
HammondCare Malvern Clinical Trials Unit - Malvern
Recruitment hospital [8] 0 0
Australian Alzheimer's Research Foundation - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - Greenwich
Recruitment postcode(s) [3] 0 0
2229 - Macquarie Park
Recruitment postcode(s) [4] 0 0
4032 - Chermside Brisbane
Recruitment postcode(s) [5] 0 0
5011 - Woodville South, Adelaid
Recruitment postcode(s) [6] 0 0
3081 - Ivanhoe
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Biogen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will be conducted to evaluate the efficacy of lecanemab in participants with early
Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo
on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18
months of treatment in the Core Study. This study will also evaluate the long-term safety and
tolerability of lecanemab in participants with EAD in the Extension Phase and whether the
long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is
maintained over time in the Extension Phase.
Trial website
https://clinicaltrials.gov/show/NCT03887455
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eisai Medical Information
Address 0 0
Country 0 0
Phone 0 0
1-888-274-2378
Fax 0 0
Email 0 0
esi_medinfo@eisai.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03887455