AzTrials
AzTrials

Alzheimer's DiseasePhase 2NCT02246075

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

A Phase 2 study testing EVP-6124 in people with Alzheimer's Disease and Dementia, run by FORUM Pharmaceuticals Inc at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer's Disease, Dementia, Cognition
What is being tested?
EVP-6124
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesUnited States
Study dates
Jul 2015to Oct 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 39Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Delray Beach, Florida

Other trials in United States

About this study

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

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.

Being tested
EVP-6124
Keywords
Alzheimer's disease, Cognition, Alpha-7 nAChR
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EVP-6124Drug

    Also called encenicline

Study groups in NCT02246075
Study groupRoleWhat they receive
EVP-6124, low doseExperimentalLow dose, Tablet, Once Daily, Day 1 through Day 168
Receives: Drug: EVP-6124
EVP-6124, high doseExperimentalHigh dose, Tablet, Once Daily, Day 1 through Day 168
Receives: Drug: EVP-6124
EVP-6124, PlaceboPlacebo comparatorPlacebo, Tablet, Once Daily, Day 1 through Day 168
Receives: Drug: EVP-6124

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety/Tolerability of EVP-6124 with concurrent memantine

    • 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

    Measured: Baseline to Day 168

Secondary outcomes (1)

  1. Change from Baseline in the Mini-Mental State Examination (MMSE)

    Measured: Baseline to Day 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2014 (estimated)
  2. Study startJul 2015
  3. Primary completionOct 2016 (estimated)

Why it stopped: Forum has decided not to proceed with this study at this time.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02246075
Sponsor's protocol ID
EVP-6124-027
Status last verified
Oct 2015
First submitted
17 Sep 2014
Last updated
15 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EVP-6124 in people with Alzheimer's Disease and Dementia, run by FORUM Pharmaceuticals Inc at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety/Tolerability of EVP-6124 with concurrent memantine (time frame: Baseline to Day 168). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02246075.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in