Study of the Safety and Effectiveness of Two Doses of Investigational Study Drug EVP-6124 in Subjects With Alzheimer's Disease
NCT ID: NCT01969136
Last Updated: 2016-05-03
Study Results
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Basic Information
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TERMINATED
PHASE3
403 participants
INTERVENTIONAL
2013-10-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental: EVP-6124, low dose
low dose, Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124
Experimental: EVP-6124, high dose
high dose, Tablet, Once Daily, Day 1 through Day 182
Drug: EVP-6124
EVP-6124, Placebo
Placebo, Tablet, Once Daily, Day 1 through Day 182
Placebo
Interventions
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Drug: EVP-6124
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
55 Years
85 Years
ALL
No
Sponsors
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FORUM Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Locations
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Tucson, Arizona, United States
Little Rock, Arkansas, United States
Culver City, California, United States
Downey, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Oceanside, California, United States
Orange, California, United States
Norwich, Connecticut, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Hallandale, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Sarasota, Florida, United States
Sunrise, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Elk Grove Village, Illinois, United States
Springfield, Illinois, United States
Newton, Massachusetts, United States
Hattiesburg, Mississippi, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Cedarhurst, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Staten Island, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Shaker Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Abington, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Plains, Pennsylvania, United States
East Providence, Rhode Island, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Richland, Washington, United States
Buenos Aires, Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Santa Fe, Santa Fe Province, Argentina
Box Hill, Victoria, Australia
Caulfield South, Victoria, Australia
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Québec, Quebec, Canada
Brno, , Czechia
Choceň, , Czechia
Hradec Králové, , Czechia
Prague, , Czechia
Richnov Nad Kneznou, , Czechia
Bordeaux, , France
Caen, , France
Paris, , France
Homburg, , Germany
Mittweida, , Germany
München, , Germany
Westerstede, , Germany
Ancona, Ancona, Italy
Milan, Milano, Italy
Saltillo, Coahuila, Mexico
Amsterdam, , Netherlands
S'Hertogenbosch, , Netherlands
The Hague, , Netherlands
Durban, KwaZulu-Natal, South Africa
Bellville, Western Cape, South Africa
George, Western Cape, South Africa
Incheon, , South Korea
Seoul, , South Korea
Madrid, Madrid, Spain
Salamanca, Salamanca, Spain
West End, Southampton, United Kingdom
Bath, , United Kingdom
Glasgow, , United Kingdom
Isleworth, , United Kingdom
Northampton, , United Kingdom
Penarth, , United Kingdom
Countries
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References
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Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
Other Identifiers
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2013-002653-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EVP-6124-025
Identifier Type: -
Identifier Source: org_study_id
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