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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/NCT01969123
Registration number
NCT01969123
Ethics application status
Date submitted
21/10/2013
Date registered
25/10/2013
Date last updated
3/05/2016
Titles & IDs
Public title
Study of the Safety and Effectiveness of Two Doses of Investigational Study Drug EVP-6124 in Subjects With Alzheimer's Disease
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-Group, 26-Week, Phase 3 Study of 2 Doses of EVP-6124 or Placebo in Subjects With Mild to Moderate Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication
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Secondary ID [1]
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2013-002618-10
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Secondary ID [2]
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EVP-6124-024
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Dementia
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Drug: EVP-6124
Treatment: Drugs - Placebo
Experimental: Experimental: EVP-6124, low dose - low dose, Tablet, Once Daily, Day 1 through Day 182
Experimental: Experimental: EVP-6124, high dose - high dose, Tablet, Once Daily, Day 1 through Day 182
Placebo Comparator: EVP-6124 Placebo - Placebo, Tablet, Once Daily, Day 1 through Day 182
Treatment: Drugs: Drug: EVP-6124
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 13-item (ADAS-Cog-13) to Day 182
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Assessment method [1]
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Timepoint [1]
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Baseline to Day 182 or Early Termination
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Primary outcome [2]
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Change from Baseline in the Clinical Dementia Rating Sum of the Boxes (CDR-SB) to Day 182
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Assessment method [2]
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Timepoint [2]
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Baseline to Day 182 or Early Termination
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Primary outcome [3]
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Safety and tolerability of EVP-6124 or Placebo in Subjects with AD
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Assessment method [3]
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All adverse experiences spontaneously reported by subject and/or observed by an investigator and repeated clinical evaluation of physical exam, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG and laboratory tests (hematology/blood chemistry/urinalysis)
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Timepoint [3]
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Baseline to Day 182 or ET
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Secondary outcome [1]
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Change from Baseline in activities of daily living using the Disability Assessment for Dementia (DAD)
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Assessment method [1]
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Timepoint [1]
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Baseline to Day 182 or Early Termination
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Secondary outcome [2]
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Change from Baseline in psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI)
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Assessment method [2]
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Timepoint [2]
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Baseline to Day 182 or Early Termination
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Secondary outcome [3]
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Change from Baseline in the Mini-Mental State Examination (MMSE)
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Assessment method [3]
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Timepoint [3]
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Baseline to Day 182 or Early Termination
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Secondary outcome [4]
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Change from Baseline in the Controlled Oral Word Association Test (COWAT)
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Assessment method [4]
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Timepoint [4]
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Baseline to Day 182 or Early Termination
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Eligibility
Key inclusion criteria
- Ages =55 and =85 years
- Informed consent form (ICF) signed by the subject or legally acceptable representative
before any study-specific procedures for the subject are performed and an ICF signed
by the support person/caregiver before any study-specific procedures for the support
person/caregiver are performed
- Clinical diagnosis of dementia due to probable AD consistent with criteria established
by a workgroup of the National Institute on Aging and the Alzheimer's Disease
Association
- Clinical decline within 12 months before screening and onset of symptoms at least 12
months or longer before screening, which may include any documented cognition,
functional, or other objective assessment or the clinical judgment of the investigator
or the subject's referring physician that the subject has experienced a clinical
decline within the last 12 months
- Magnetic resonance imaging (MRI) or computed tomography (CT) scan performed within 12
months before screening, with findings consistent with the diagnosis of dementia due
to AD without any other clinically significant comorbid pathologies. If an MRI or CT
scan is unavailable or occurred greater than 12 months before screening, this
assessment should be completed and the findings confirmed before the subject enters
the run-in period (Day -14) (copy of the report will be available at the study site)
- Mini-Mental State Examination (MMSE) score =14 and =24 at screening and confirmed on
Day 1 prior to randomization (fluctuations of ±2 points are acceptable on Day
1/baseline)
- Clinical Dementia Rating Global score (CDR-GS) =1 (at least mild dementia) at
screening and confirmed on Day 1 prior to randomization
- Modified Hachinski Ischemic Scale (mHIS) score =4 at screening
- Fertile, sexually active subjects (men and women) must use an effective method of
contraception during the study. Female subjects and the female partner of male
subjects must be surgically sterile (hysterectomy or bilateral tubal ligation),
postmenopausal for at least 1-year, or willing to practice adequate methods of
contraception if of childbearing potential (defined as consistent use of combined
effective methods of contraception [including at least 1 barrier method])
- Reliable and capable support person/caregiver, who if not living in the same
household, interacts with the subject approximately 4 times per week and will be
available to attend clinic visits in person when possible
- Subject living at home, senior residential setting, or an institutional setting
without the need for continuous (ie, 24-hour) nursing care
- General health status acceptable for participation in a 26-week study
- Fluency (oral and written) in the language in which the standardized tests will be
administered
- Receiving a stable dose of an acetylcholinesterase inhibitor (AChEI) (donepezil,
rivastigmine or galantamine) for at least 3 months (90 days) before screening and with
continuous dosing for at least 6 months OR not presently receiving an AChEI (at least
30 days before screening), but with a history of previous AChEI treatment (subjects
receiving donepezil 23 mg currently or within 3 months before screening are
ineligible)
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Minimum age
55
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Exposure to an experimental drug, experimental biologic or experimental medical device
within 2 months (60 days) before screening
- Prior participation in an amyloid vaccination clinical study at any time in the past
or completion of a passive amyloid vaccination study within 6 months before screening
- Inability to swallow a tablet
- In the judgment of the investigator, inability of the subject or the support
person/caregiver to complete a 26-week study
- Inability to be =75% compliant with single-blind study drug
- Inability to adequately cooperate or complete the cognitive testing procedures or any
study assessment
- Residence in a skilled nursing facility
- Untreated vitamin B12 or folate deficiency (if treated, must be stably treated for at
least 6 months before screening)
- Clinically significant (in the judgment of the investigator) abnormal serum
electrolytes (sodium, potassium, magnesium) after repeat testing
- Clinically significant untreated hypothyroidism (if treated, thyroid-stimulating
hormone level and thyroid supplementation dose must be stable for at least 6 months
before screening)
- Insufficiently controlled diabetes mellitus (in the judgment of the investigator) or
requiring insulin
- Renal insufficiency (serum creatinine >2.0 mg/dL)
- Malignant tumor within 3 years before screening (except squamous and basal cell
carcinoma or cervical carcinoma in situ or localized prostate cancer)
- Female subjects who are pregnant, nursing, or planning to become pregnant during the
study
- Unstable medical condition that is clinically significant in the judgment of the
investigator
- Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times the upper limit
of normal
- History of myocardial infarction or unstable angina within 6 months before screening
- History of more than 1 myocardial infarction within 5 years before screening
- Clinically significant (in the judgment of the investigator) cardiac arrhythmia
(including atrial fibrillation), cardiomyopathy, or cardiac conduction defect
(subjects with a pacemaker are acceptable)
- Symptomatic hypotension or hypertension (supine diastolic blood pressure >95 mmHg) (in
the judgment of the investigator)
- Clinically significant abnormality on screening or baseline electrocardiogram (ECG),
including but not necessarily limited to a confirmed corrected QT interval (QTc) value
=450 msec for males or =470 msec for females. In subjects with a QRS value >120msec,
those with a QTc value <500 msec may be eligible following discussion with the Medical
Monitor.
- Stroke within 18 months before screening, or history of a stroke concomitant with
onset of dementia
- History of brain tumor, subdural hematoma, or other clinically significant (in the
judgment of the investigator) space-occupying lesion on CT or MRI
- Head trauma with clinically significant (in the judgment of the investigator) loss of
consciousness within 12 months before screening or concurrent with the onset of
dementia
- Onset of dementia secondary (in the judgment of the investigator) to cardiac arrest,
surgery with general anesthesia, or resuscitation
- Specific degenerative central nervous system (CNS) disease diagnosis other than AD
(eg, Huntington's disease, Creutzfeld-Jacob disease, Down's syndrome, Fronto-Temporal
Dementia, Parkinson's disease)
- Subjects with no history of prior treatment with an AChEI (donepezil, rivastigmine, or
galantamine)
- Memantine currently or within 30 days before screening
- Antipsychotics; low doses (in the judgment of the investigator, except clozapine) are
allowed only if given for sleep disturbances, agitation and/or aggression, and only if
the subject has received a stable dose for at least 3 months before screening (but not
within 8 hours before any cognitive test)
- Tricyclic antidepressants and monoamine oxidase inhibitors; all other antidepressants
are allowed only if the subject has received a stable dose for at least 3 months
before screening
- Antiepileptic medications if taken for control of seizures
- Chronic intake of opioid-containing analgesics
- Sedating H1 antihistamines
- Nicotine therapy (including the patch), varenicline (Chantix), or similar therapeutic
agent within 30 days before screening
- Clinically significant urine drug screen or serum alcohol test result in the judgment
of the investigator
- History of ischemic colitis or ischemic enterocolitis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2017
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Actual
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Sample size
Target
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Accrual to date
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Final
474
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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- Hornsby
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Recruitment hospital [2]
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- Geelong
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Recruitment hospital [3]
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- West Heidelberg
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Recruitment postcode(s) [1]
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- Hornsby
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Recruitment postcode(s) [2]
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- Geelong
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Recruitment postcode(s) [3]
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- West Heidelberg
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Recruitment outside Australia
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Arizona
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California
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Florida
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Burgos
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
FORUM Pharmaceuticals Inc
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124
compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease
currently receiving stable treatment or previously treated with an acetylcholinesterase
inhibitor.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01969123
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01969123
Download to PDF