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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03114657




Registration number
NCT03114657
Ethics application status
Date submitted
28/03/2017
Date registered
14/04/2017
Date last updated
4/10/2019

Titles & IDs
Public title
A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
Scientific title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease
Secondary ID [1] 0 0
2016-003288-20
Secondary ID [2] 0 0
BN29553
Universal Trial Number (UTN)
Trial acronym
CREAD 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Crenezumab
Treatment: Drugs - Placebo

Experimental: Crenezumab - Participants will receive IV infusion of crenezumab q4w for 100 weeks.

Placebo Comparator: Placebo - Participants will receive IV infusion of placebo q4w for 100 weeks.


Treatment: Drugs: Crenezumab
Crenezumab will be administered as IV infusion q4w for 100 weeks.

Treatment: Drugs: Placebo
Placebo will be administered as IV infusion q4w for 100 weeks.

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

Outcomes
Primary outcome [1] 0 0
Change from Baseline to Week 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scale Score
Timepoint [1] 0 0
Baseline, Week 105
Secondary outcome [1] 0 0
Change from Baseline to Week 105 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) and Alzheimer's Disease Assessment Scale-Cognition 11 (ADAS-Cog-11) Subscale Score
Timepoint [1] 0 0
Baseline, Week 105
Secondary outcome [2] 0 0
Change from Baseline to Week 105 in Clinical Dementia Rating-Global Score (CDR-GS) and Mini Mental State Exam MMSE
Timepoint [2] 0 0
Baseline, Week 105
Secondary outcome [3] 0 0
Change from Baseline to Week 105 on Function as assessed by (ADCS-ADL) Total Score and Its (ADCS-iADL) and by the Functional Activities Questionnaire (FAQ) total score
Timepoint [3] 0 0
Baseline, Week 105
Secondary outcome [4] 0 0
Change from Baseline to Week 105 on a Measure of Dependence Level Assessed from the ADCS-ADL Score
Timepoint [4] 0 0
Baseline, Week 105
Secondary outcome [5] 0 0
Change from Baseline to Week 105 on Behavior in Neuropsychiatric Inventory Questionnaire (NPI-Q) Total Score
Timepoint [5] 0 0
Baseline, Week 105
Secondary outcome [6] 0 0
Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score
Timepoint [6] 0 0
Baseline, Week 105
Secondary outcome [7] 0 0
Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score
Timepoint [7] 0 0
Baseline, Week 105
Secondary outcome [8] 0 0
European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores
Timepoint [8] 0 0
Baseline, Week 105
Secondary outcome [9] 0 0
Percentage of Participants with Adverse Event (AEs) and Serious Adverse Event (SAEs)
Timepoint [9] 0 0
Baseline up to Week 105
Secondary outcome [10] 0 0
Percentage of Participants with Anti-Crenezumab Antibodies
Timepoint [10] 0 0
Baseline up to Week 105
Secondary outcome [11] 0 0
Serum Concentration of Crenezumab
Timepoint [11] 0 0
Pre-infusion (0 hour), 60-90 minutes post-infusion on Day 1 Week 1 and on Week 25; Weeks 5, 13, 37, 53, and 100 (infusion length = as per the Pharmacy Manual)
Secondary outcome [12] 0 0
Plasma Amyloid Beta (Abeta) Concentrations
Timepoint [12] 0 0
Screening (Weeks -8 to -1) ; Day 1 Week 1; Weeks 5, 25, 53, and 100
Secondary outcome [13] 0 0
Change from Baseline to Week 105 in Brain Volume as Determined by Magnetic Resonance Imaging (MRI)
Timepoint [13] 0 0
Baseline, Week 105
Secondary outcome [14] 0 0
Cerebrospinal Fluid (CSF) concentration of Crenezumab
Timepoint [14] 0 0
At pre-defined intervals from baseline through week 105
Secondary outcome [15] 0 0
Brain Amyloid Load Over Time Measured by Amyloid-PET
Timepoint [15] 0 0
At pre-defined intervals from baseline through week 105
Secondary outcome [16] 0 0
Brain Tau Load Over Time Measured by Tau-PET
Timepoint [16] 0 0
At pre-defined intervals from baseline through week 105
Secondary outcome [17] 0 0
Cerebrospinal Fluid (CSF) Markers of Disease Over Time
Timepoint [17] 0 0
At pre-defined intervals from baseline through week 105

Eligibility
Key inclusion criteria
- Weight between 40 and 120 kilograms (kg), inclusive

- Availability of a person (referred to as the "caregiver") who in the investigator's
judgment : (a) Has frequent and sufficient contact with the participant to be able to
provide accurate information regarding the participant's cognitive and functional
abilities, agrees to provide information at clinic visits (which require partner input
for scale completion), signs the necessary consent form, and has sufficient cognitive
capacity to accurately report upon the participant's behavior and cognitive and
functional abilities; (b) Is in sufficiently good general health to have a high
likelihood of maintaining the same level of interaction with the participant and
participation in study procedures throughout the study duration

- Fluency in the language of the tests used at the study site

- Adequate visual and auditory acuity, in the investigator's judgment, sufficient to
perform the neuropsychological testing (eye glasses and hearing aids are permitted)

- Evidence of the AD pathological process, by a positive amyloid assessment either on
cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys
beta-amyloid (1-42) test system or amyloid positron emission tomography (PET) scan by
qualitative read by the core/central PET laboratory

- Demonstrated abnormal memory function at early screening (up to 4 weeks before
screening begins) or at screening

- Evidence of retrospective decline confirmed by a diagnosis verification form

- Mild symptomatology, as defined by a screening MMSE score of >=22 points and CDR-GS of
0.5 or 1.0

- Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical
criteria for probable AD dementia or prodromal AD (consistent with the NIAAA
diagnostic criteria and guidelines for mild cognitive impairment [MCI])

- If receiving symptomatic AD medications, the dosing regimen must have been stable for
3 months prior to screening. If the participant is taking medical food supplements,
these must also have been stable for 3 months prior to screening

- Participant must have completed at least 6 years of formal education after the age of
5 years

- For enrollment into the China Extension Phase, participants must have residence in
mainland China, Hong Kong or Taiwan and be of Chinese ancestry
Minimum age
50 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any evidence of a condition other than AD that may affect cognition, including but not
limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia,
Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive
supranuclear palsy, frontotemporal degeneration, Huntington's disease, normal pressure
hydrocephalus, seizure disorder, or hypoxia

- Seizure history that, in the opinon of the investigator, is likely to results in
cognitive impairment

- History of schizophrenia, schizoaffective disorder, major depression, or bipolar
disorder

- At risk of suicide in the opinion of the investigator

- Presence of significant cerebral vascular pathology as assessed by MRI central reader

- Unstable or clinically significant cardiovascular, kidney or liver disease

- Uncontrolled hypertension

- Screening hemoglobin A1c (HbA1C) greater than (>) 8 percent (%)

- Clinical significant sleep apnea that may be contributing to cognitive impairment.
Sleep apnea, which in the clinical judgement of the investigator is adequately treated
is allowed

- Poor peripheral venous access

- History of cancer except if considered to be cured or If not being actively treated
with anti-cancer therapy or radiotherapy

- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric, human, or humanized antibodies or fusion proteins

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 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Central Coast Neurosciences Research - Erina
Recruitment hospital [3] 0 0
Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care - Hornsby
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital; Neurology - Woodville
Recruitment hospital [5] 0 0
St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research - Fitzroy
Recruitment hospital [6] 0 0
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre - Heidelberg West
Recruitment hospital [7] 0 0
Royal Melbourne Hospital; Department of Neurology - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2250 - Erina
Recruitment postcode(s) [3] 0 0
2077 - Hornsby
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [7] 0 0
3050 - Parkville
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Samsun
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Bath
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Cheltenham
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Edinburgh
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Glasgow
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Kilmarnock
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L7 8xp
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London
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Manchester
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Oxford
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Sheffield
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Southampton
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Stoke on Trent
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United Kingdom
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Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the
efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD.
Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab
or placebo every 4 weeks (q4w) for 100 weeks. The primary efficacy assessment will be
performed at 105 weeks. The participants who do not enter open-label extension will enter for
a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).
Trial website
https://clinicaltrials.gov/show/NCT03114657
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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
Other publications