Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02246075
Recruitment Status : Withdrawn (Forum has decided not to proceed with this study at this time.)
First Posted : September 22, 2014
Last Update Posted : October 15, 2015
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
FORUM Pharmaceuticals Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Cognition Drug: EVP-6124 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 24-Week, Phase 2 Study of Two Doses of EVP-6124 Hydrochloride or Placebo in Subjects With Mild to Moderate Alzheimer's Disease Currently Receiving Memantine Medication With or Without Additional Acetylcholinesterase Inhibitor Co-Medication
Study Start Date : July 2015
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Memantine

Arm Intervention/treatment
Experimental: EVP-6124, low dose
Low dose, Tablet, Once Daily, Day 1 through Day 168
Drug: EVP-6124
Other Name: encenicline

Experimental: EVP-6124, high dose
High dose, Tablet, Once Daily, Day 1 through Day 168
Drug: EVP-6124
Other Name: encenicline

Placebo Comparator: EVP-6124, Placebo
Placebo, Tablet, Once Daily, Day 1 through Day 168
Drug: EVP-6124
Other Name: encenicline




Primary Outcome Measures :
  1. Safety/Tolerability of EVP-6124 with concurrent memantine [ Time Frame: Baseline to Day 168 ]
    • Number of subjects with AEs
    • Percentage of subjects with AEs
    • Number of subjects with SAEs
    • Percentage of subjects with SAEs
    • Number of subjects who discontinue due to AEs
    • Percentage of subjects who discontinue due to AEs
    • Number of subject deaths
    • Percentage of subject deaths


Secondary Outcome Measures :
  1. Change from Baseline in the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline to Day 168 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

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 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)
  • Wernicke's encephalopathy
  • Active acute or chronic CNS infection
  • Donepezil 23 mg QD currently or within 3 months prior to randomization
  • Discontinued AChEI <30 days prior to randomization
  • 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 randomization
  • 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 randomization
  • Anxiolytics or sedative-hypnotics, including barbiturates (unless given in low doses for benign tremor); low doses of benzodiazepines and zolpidem (in the judgment of the investigator) are allowed only if given for insomnia/sleep disturbance, and only if the subject has received a stable dose for at least 3 months before randomization
  • Peripherally acting drugs with effects on cholinergic transmission
  • Immunosuppressants, including systemic corticosteroids, if taken in clinically immunosuppressive doses in the judgment of the investigator (Note: steroid use for allergy or other inflammation is permitted)
  • Antiepileptic medications if taken for control of seizures
  • Chronic intake of opioid-containing analgesics
  • Sedating H1 antihistamines
  • Nicotine therapy (all dosage forms including a patch), varenicline (Chantix), or similar therapeutic agent within 30 days before screening
  • Clinically significant urine drug screen (UDS) or serum alcohol test result in the judgment of the investigator (including medical marijuana)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246075


Locations
Layout table for location information
United States, Florida
Delray Beach, Florida, United States
United States, New Mexico
Albuquerque, New Mexico, United States
Sponsors and Collaborators
FORUM Pharmaceuticals Inc
Quintiles, Inc.

Layout table for additonal information
Responsible Party: FORUM Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02246075     History of Changes
Other Study ID Numbers: EVP-6124-027
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: October 2015
Keywords provided by FORUM Pharmaceuticals Inc:
Alzheimer's disease
Cognition
Alpha-7 nAChR
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents