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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02569398




Registration number
NCT02569398
Ethics application status
Date submitted
5/10/2015
Date registered
6/10/2015
Date last updated
10/02/2020

Titles & IDs
Public title
An Efficacy and Safety Study of Atabecestat in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia
Scientific title
A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Study Investigating the Efficacy and Safety of JNJ-54861911 in Subjects Who Are Asymptomatic At Risk for Developing Alzheimer's Dementia
Secondary ID [1] 0 0
2015-000948-42
Secondary ID [2] 0 0
CR107373
Universal Trial Number (UTN)
Trial acronym
EARLY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asymptomatic Amyloid-positive 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atabecestat, 5 mg
Treatment: Drugs - Atabecestat, 25 mg
Treatment: Drugs - Placebo

Experimental: Group 1 - Participants will receive one atabecestat, 5 milligram (mg) tablet orally once daily up to 54 months.

Experimental: Group 2 - Participants will receive one atabecestat, 25 mg tablet orally once daily up to 54 months.

Experimental: Group 3 - Participants will receive one matching placebo tablet orally once daily up to 54 months.


Treatment: Drugs: Atabecestat, 5 mg
One atabecestat, 5 mg tablet orally once daily up to 54 months.

Treatment: Drugs: Atabecestat, 25 mg
One atabecestat, 25 mg tablet orally once daily up to 54 months.

Treatment: Drugs: Placebo
One matching placebo tablet orally once daily up to 54 months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Preclinical Alzheimer Cognitive Composite (PACC) Score at Endpoint (Month 24)
Timepoint [1] 0 0
Baseline and Endpoint (Month 24)
Secondary outcome [1] 0 0
Change From Baseline in Cognitive Function Index (CFI) Score at Endpoint (Month 24)
Timepoint [1] 0 0
Baseline and Endpoint (Month 24)
Secondary outcome [2] 0 0
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Prevention Instrument (ADCS-ADLPI) Total Score at Endpoint (Month 24)
Timepoint [2] 0 0
Baseline and Endpoint (Month 24)
Secondary outcome [3] 0 0
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score at Endpoint (Month 24)
Timepoint [3] 0 0
Baseline and Endpoint (Month 24)
Secondary outcome [4] 0 0
Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score at Endpoint (Month 24)
Timepoint [4] 0 0
Baseline and Endpoint (Month 24)
Secondary outcome [5] 0 0
Change From Baseline in Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score at Endpoint (Month 24)
Timepoint [5] 0 0
Baseline and Endpoint (Month 24)

Eligibility
Key inclusion criteria
- Participant must have a global Clinical Dementia Rating Scale- (CDR) score of '0' at
Screening

- Participants 60 to 64 years of age must also have 1 of the following 3 conditions: a)
a positive family history for dementia (minimum of 1 first degree relative), b) a
previously known apolipoprotein E, e4 allele (APOE ?4) genotype, c) a previously known
biomarker status demonstrating elevated amyloid accumulation in cerebrospinal fluid
(CSF) or positron emission tomography (PET)

- Participant must be able to read and write and must have adequate hearing and visual
acuity to complete the psychometric tests. The legally acceptable representative must
also be able to read and write

- Participants must have evidence of amyloid accumulation by means of either: a) low
Cerebrospinal Fluid (CSF) ABeta 1-42 levels at Screening; b) a positive amyloid
positron emission tomography (PET) scan at Screening (depending on the site's PET
capability) by visual read

- Participant must be otherwise healthy for their age group or medically stable with or
without medication on the basis of physical examination, medical history, vital signs,
and 12-lead electrocardiogram (ECG) performed at Screening or at Baseline
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participant is receiving an acetylcholinesterase (AChE) inhibitor and/or memantine at
any time during Screening or Day 1 predose

- Participant has evidence of any brain diseases, other than potential very early signs
of Alzheimer's Dementia (AD) (example. mild hippocampal atrophy) or typical
age-related changes (e.g. mild white matter hyperintensity on magnetic resonance
imaging [MRI]) or any other abnormality (e.g. folic acid/Vitamin B12 deficiency) that
could explain a possible cognitive deficit (including, but not limited to vascular
encephalopathy or large strokes (as imaged by cerebral MRI)

- Participant has any contraindications for MRI (example, prostheses, implants,
claustrophobia, pacemaker)

- Participant has met criteria for dementia or has a brain disorder that can cause
dementia

- Participant has evidence of familial autosomal dominant AD (mutation identified in the
family and/or participant prior to randomization)

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2018
Sample size
Target
Accrual to date
Final
557
Recruitment in Australia
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- Adelaide
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- Brisbane
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- Darlinghurst
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- Heidelberg
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- Herston
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- Subiaco
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- Tarren Point
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- Waratah
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- Adelaide
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- East Gosford
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- Heidelberg
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- Herston
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- Subiaco
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- Tarren Point
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- Waratah
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate whether treatment with atabecestat slows cognitive
decline compared with placebo treatment, as measured by a composite cognitive measure, the
Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are
asymptomatic at risk for developing Alzheimer's dementia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02569398
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02569398