Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease
|
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: NCT01073228 |
|
Recruitment Status :
Completed
First Posted : February 23, 2010
Last Update Posted : April 25, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease Central Nervous System Diseases Cognition | Drug: EVP-6124 Drug: Placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 409 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, 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 |
| Study Start Date : | April 2010 |
| Actual Primary Completion Date : | November 2011 |
| Actual Study Completion Date : | February 2012 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: EVP-6124 0.3 mg
one 0.3 mg capsule every day for 183 days
|
Drug: EVP-6124 |
|
Active Comparator: EVP-6124 1 mg
one 1 mg capsule every day for 183 days
|
Drug: EVP-6124 |
|
Active Comparator: EVP-6124 2 mg
one 2 mg capsule every day for 183 days
|
Drug: EVP-6124 |
|
Placebo Comparator: Placebo
Placebo every day for 183 days
|
Drug: Placebo |
- Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13) [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ]
- 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 ]
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.
| Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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
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): NCT01073228
Show 54 study locations
| Responsible Party: | FORUM Pharmaceuticals Inc |
| ClinicalTrials.gov Identifier: | NCT01073228 |
| Other Study ID Numbers: |
EVP-6124-010 |
| First Posted: | February 23, 2010 Key Record Dates |
| Last Update Posted: | April 25, 2014 |
| Last Verified: | February 2013 |
|
Alzheimer's disease Central Nervous System diseases Cognition |
|
Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Dementia Brain Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |