Alzheimer's DiseasePhase 2NCT01073228
Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing EVP-6124 in people with Alzheimer's Disease and Central Nervous System Diseases, run by FORUM Pharmaceuticals Inc at 54 sites in 5 countries.
Trial summary
This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease, Central Nervous System Diseases, 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
- 409 participants
- Where
- 54 sitesin 5 countries
- Study dates
- Apr 2010to Feb 2012
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Probable Alzheimer's disease
- Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment
- Modified Hachinski Ischemic Score (mHIS) ≤4 at screening
- Female subjects are ≥1 year post-menopausal or are surgically sterile
- Caregiver available; if not living in the same household, caregiver sees subject at least four times each week
- Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care
- General health status acceptable for participation in a 24 week clinical trial be administered
Who cannot join
- General
- Participation in another therapeutic clinical trial within 30 days before Baseline
- Prior participation in an amyloid vaccination clinical study
- Inability to swallow capsules
- Likely inability to complete 24 week study
- Inability to be ≥75% compliant with single-blind placebo run-in medication
Show all 13Show fewer
- Inability to adequately perform cognitive tests
- History of significant cardiovascular disease
- Major depression
- Psychosis
- History of stroke within 18 months of screening
- Head trauma
- Inability to perform any screening or baseline evaluations
Trial locations and contacts
54 sites in 5 countries.
54 sites in 5 countries
United States25 sites
The Memory Clinic
Bennington, Vermont, 05201
Brooklyn Medical Institute
Brooklyn, New York, 11214
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Meridien Research
Brooksville, Florida, 34601
Catalina Research Institute
Chino, California, 91710
Columbus Research and Wellness Institute
Columbus, Ohio, 31909
ATP Clinical Research
Costa Mesa, California, 92626
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231
Brain Matters Research
Delray Beach, Florida, 33445
Advanced Bio Behavioral Sciences Inc.
Elmsford, New York, 10523
MD Clinical
Hallandale, Florida, 33009
Galiz Research
Miami Springs, Florida, 33166
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, 06851
Renstar Medical Research
Ocala, Florida, 34471
University of California, Irvine
Orange, California, 92868
Compass Research, LLC
Orlando, Florida, 32806
HOPE Research Institute
Phoenix, Arizona, 85050
Summit Research Network
Portland, Oregon, 97210
Princeton Medical Institute
Princeton, New Jersey, 08540
University of Rochester Medical Center at MCH
Rochester, New York, 14620
Radiant Research
Santa Rosa, California, 95405
Memory Enhancement Center of NJ
Toms River, New Jersey, 08755
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
The Center for Excellence in Aging and Geriatric Health
Williamsburg, Virginia, 23185
Russia10 sites
Study site
Kazan', 420064
Clinical Site 1
Moscow, 115552
Clinical Site 2
Moscow
Clinical Site 1
Saint Petersburg, 190005
Clinical Site 2
Saint Petersburg, 190103
Clinical Site 3
Saint Petersburg, 194175
Clinical Site 4
Saint Petersburg
Study site
Saratov, 410060
Study site
Voronezh, 394052
Study site
Yekaterinburg
Romania8 sites
Clinical Site 1
Bucharest
Clinical Site 2
Bucharest
Clinical Site 3
Bucharest
Clinical Site 4
Bucharest
Clinical Site 5
Bucharest
Study site
Iași, 700282
Study site
Oradea, 410154
Study site
Târgu Mureş
Ukraine7 sites
Study site
Dnipro, 490005
Study site
Donets'k, 83037
(1)
Kyiv, 04080
(2)
Kyiv, 04080
Study site
Odesa, 65006
Study site
Simferopol, 95006
Study site
Vinnytsia, 21005
Serbia4 sites
Clinical site 1
Belgrade, 11000
Clinical Site 2
Belgrade, 11000
Study site
Kragujevac, 34000
Study site
Niš, 18000
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Parallel, 24-Week, Phase 2 Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Subjects With Mild to Moderate Probable Alzheimer's Disease
This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication.
Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.
- Being tested
- EVP-6124, Placebo
- Keywords
- Alzheimer's disease, Central Nervous System diseases, Cognition
- Medical subject headings
- Alzheimer Disease, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVP-6124Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| EVP-6124 0.3 mg | Active comparator | one 0.3 mg capsule every day for 183 days Receives: Drug: EVP-6124 |
| EVP-6124 1 mg | Active comparator | one 1 mg capsule every day for 183 days Receives: Drug: EVP-6124 |
| EVP-6124 2 mg | Active comparator | one 2 mg capsule every day for 183 days Receives: Drug: EVP-6124 |
| Placebo | Placebo comparator | Placebo every day for 183 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)
Measured: Day -7, Baseline, 4, 12, 18, 23 Weeks
Secondary outcomes (7)
Alzheimer's Disease Assessment Scale-Cognitive subscale-11
Measured: 4, 12, 18, 23 Weeks
Controlled Oral Word Association Test
Measured: Day -7, Baseline, 4, 12, 18, 23 Weeks
Category Fluency Test
Measured: Day -7, Baseline, 4, 12, 18, 23 Weeks
Clinical Dementia Rating Scale Sum of Boxes
Measured: Day -7, Baseline, 4, 12, 18, 23 Weeks
Alzheimer's Disease Cooperative Study-Activities of Daily Living
Measured: Baseline, 4, 12, 18, 23 Weeks
Neuropsychiatric Inventory
Measured: Baseline, 12, 23 Weeks
Mini-Mental State Exam
Measured: Day -7, Baseline, 4, 12, 18, 23 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- FORUM Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INC Research Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073228
- Sponsor's protocol ID
- EVP-6124-010
- Status last verified
- Feb 2013
- First submitted
- 19 Feb 2010
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Parallel, 24-Week, Phase 2 Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Subjects With Mild to Moderate Probable Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01073228
- Acronym / sponsor ID
- EVP-6124-010
- Keywords
- Alzheimer's disease, Central Nervous System diseases, Cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- FORUM Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Collaborators
- INC Research Limited
- Study start
- Apr 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication.
Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EVP-6124 0.3 mg | Active comparator | Drug: EVP-6124one 0.3 mg capsule every day for 183 days |
| EVP-6124 1 mg | Active comparator | Drug: EVP-6124one 1 mg capsule every day for 183 days |
| EVP-6124 2 mg | Active comparator | Drug: EVP-6124one 2 mg capsule every day for 183 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo every day for 183 days |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with Probable Alzheimer's disease
- Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment
- Modified Hachinski Ischemic Score (mHIS) ≤4 at screening
- Female subjects are ≥1 year post-menopausal or are surgically sterile
- Caregiver available; if not living in the same household, caregiver sees subject at least four times each week
Key exclusion criteria (13 listed)
- General
- Participation in another therapeutic clinical trial within 30 days before Baseline
- Prior participation in an amyloid vaccination clinical study
- Inability to swallow capsules
- Likely inability to complete 24 week study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVP-6124 | Drug | EVP-6124 0.3 mg, EVP-6124 1 mg, EVP-6124 2 mg |
| Placebo | Drug | Placebo |
Primary outcome
Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)
Time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
7 secondary outcomes
Alzheimer's Disease Assessment Scale-Cognitive subscale-11
Time frame: 4, 12, 18, 23 Weeks
Controlled Oral Word Association Test
Time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Category Fluency Test
Time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Clinical Dementia Rating Scale Sum of Boxes
Time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Alzheimer's Disease Cooperative Study-Activities of Daily Living
Time frame: Baseline, 4, 12, 18, 23 Weeks
Neuropsychiatric Inventory
Time frame: Baseline, 12, 23 Weeks
Mini-Mental State Exam
Time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVP-6124 in people with Alzheimer's Disease and Central Nervous System Diseases, run by FORUM Pharmaceuticals Inc at 54 sites in 5 countries.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Russia, Romania, Ukraine, Serbia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13) (time frame: Day -7, Baseline, 4, 12, 18, 23 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2014.