Alzheimer's Disease Education and Referral Center

EVP-6124 for Treating Alzheimer's Disease

EVP-6124 for Treating Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

This Phase III clinical trial will evaluate the safety and efficacy of two doses of EVP-6124, compared to a placebo, in people with mild to moderate Alzheimer's disease who take or have taken an Alzheimer's disease medication (acetylcholinesterase inhibitor).

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
85 Years
Both
No
Inclusion Criteria: 
    • Clinical diagnosis of dementia due to probable Alzheimer's disease, consistent with criteria established the National Institute on Aging and the Alzheimer's Association
    • Clinical decline within 12 months before screening and onset of symptoms at least 12 months or longer before screening
    • Magnetic resonance imaging or computed tomography scan performed within 12 months before screening; findings consistent with diagnosis of Alzheimer's dementia, without any other clinically significant comorbid pathologies
    • Mini-Mental State Examination score of 14-24 (inclusive) and Clinical Dementia Rating Global score of 1 or higher (at least mild dementia) at screening and confirmed on Day 1 prior to randomization
    • Modified Hachinski Ischemic Scale score of 4 or less at screening
    • Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study; female subjects and the female partners of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1 year, or willing to use adequate contraception if of childbearing potential
    • Reliable, capable support person/caregiver who, if not living in the same household, interacts with the subject about four times per week and can attend clinic visits in person when possible
    • Living at home, a senior residential setting, or an institutional setting without the need for 24-hour nursing care
    • Good general health status
    • Fluency (oral and written) in the language in which standardized tests will be administered
    • Taking an acetylcholinesterase inhibitor (donepezil, rivastigmine or galantamine) for at least 6 months before screening, on a stable dose for at least 3 months; history of treatment with acetylcholinesterase inhibitor also acceptable (subjects receiving 23-mg donepezil within 3 months before screening are ineligible)
Exclusion Criteria: 
    • Exposure to an experimental drug, biologic, or medical device within 2 months before screening; 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
    • Living 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 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 or diabetes requiring insulin
    • Renal insufficiency (serum creatinine >2.0 mg/dL)
    • Malignant tumor within 3 years before screening (except squamous and basal cell carcinoma, cervical carcinoma in situ, or localized prostate cancer)
    • Female subjects who are pregnant, nursing, or planning to become pregnant during the study
    • History of colitis or ischemic enterocolitis
    • Clinically significant unstable medical condition or history of such a condition:
      • History of myocardial infarction or unstable angina within 6 months before screening or more than one myocardial infarction within 5 years before screening
      • Cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (pacemaker is acceptable)
      • 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 space-occupying lesion shown by brain imaging
      • Head trauma with loss of consciousness within 12 months before screening or concurrent with the onset of dementia
    • Alanine transaminase or aspartate transaminase more than 2.5 times the upper limit of normal
    • Symptomatic hypotension or hypertension (supine diastolic blood pressure of more than 95 mmHg)
    • Clinically significant abnormality on screening or baseline electrocardiogram; clinically significant urine drug screen or serum alcohol test result
    • Onset of dementia secondary to cardiac arrest, surgery with general anesthesia, or resuscitation
    • Specific degenerative central nervous system disease diagnosis other than Alzheimer's disease (e.g., Huntington's disease, Creutzfeld-Jacob disease, Down's syndrome, frontotemporal dementia, Parkinson's disease)
    • Prohibited medications:
      • 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
      • 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
      • Parkinson's medications
      • Epilepsy 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
Detailed Description: 

During this 26-week study, participants will take either one of two doses of the test drug EVP-6124 or a placebo. Tests of cognitive performance and daily function will be conducted to gauge the drug's effectiveness. EVP-6124 is a tablet, taken once daily, containing a compound that acts on nicotinic acetylcholine receptors in areas of the brain that are important for cognition. EnVivo’s previous research has demonstrated that memory deficits can be minimized or entirely reversed by activating the alpha-7 receptor with EVP-6124 alone or in combination with acetylcholinesterase inhibitors. EVP-6124 has also been shown to increase the release of important neurotransmitters.

Central Contact Information: 

For more information about this trial or study sites, please contact Sophie Guillaume at 1-617-374-5705 or sguillaume@forumpharma.com.

Locations: 
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Tucson
Arizona
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Little Rock
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Culver City
California
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Downey
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Los Alamitos
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Orange
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Norwich
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Atlanta
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Elk Grove Village
Illinois
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Park Ridge
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Springfield
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Newton
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Hattiesburg
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Albuquerque
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Albany
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Cedarhurst
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New Hyde Park
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New York
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Charlotte
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Durham
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Shaker Heights
Ohio
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Oklahoma City
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Abington
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Plains
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East Providence
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Houston
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Salt Lake City
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Charlottesville
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Richland
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Halifax
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London
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Quebec
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Saltillo
Coahuila
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Lead Sponsor: 
Agency
FORUM Pharmaceuticals, Inc.
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
NamePhoneEmail
Sophie Guillaume
617-374-5705
Locations
 
 
ClinicalTrials.gov ID 
Official 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 Medicat
Study Start Date: 
October 2013
Study End Date: 
January 2017
Disease Stage: 
Early
Middle
Enrollment: 
790