Study of the Safety of Two Doses of Investigational Study Drug EVP-6124 in Subjects With Alzheimer's Disease Currently Receiving Memantine

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease, Dementia, Cognition

In brief

The purpose of this study is to evaluate the safety of 2 fixed doses of EVP-6124 hydrochloride (HCl) compared to placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease who are concurrently receiving stable treatment with memantine and currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor.

Key facts

Study ID: NCT02246075
Run by: FORUM Pharmaceuticals Inc
People needed: 0
Starts: 2015-07-01
Last updated by the study team: 2015-10-15

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 possible or probable AD consistent with criteria established by a workgroup of the National Institute on Aging and the Alzheimer's Disease Association
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 ≥12 and ≤26 at screening
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 regularly and will help facilitate clinic visits of the study subject
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 24-week study
Fluency (oral and written) in the language in which the standardized tests will be administered
Receiving a stable dose of memantine for at least 3 months (90 days) before screening and with continuous dosing for at least 3 months. Additional co-medication with an AChEI (donepezil in any dose form other than 23 mg once daily (QD), rivastigmine or galantamine) is allowed if stable for at least 3 months (90 days) before screening with total continuous exposure for at least 3 months.

You may not qualify if…

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 to complete a 24-week study
Residence in a skilled nursing facility
Inability to be ≥75% compliant with single-blind study drug
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)
History of ischemic colitis or ischemic enterocolitis
Unstable medical condition that is clinically significant in the judgment of the investigator
Female subjects who are pregnant, nursing, or planning to become pregnant during the study
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 uncontrolled hypertension (in the judgment of the investigator)
Clinically significant abnormality on screening electrocardiogram (ECG), including but not necessarily limited to a confirmed 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 CNS disease diagnosis other than AD (eg, Huntington's disease, Creutzfeld-Jacob disease, Down's syndrome, Fronto-Temporal Dementia, Parkinson's disease)

Where it is running

Study site — Delray Beach, Florida, United States
Study site — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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