Alzheimer's DiseasePhase 3NCT00090116
The Safety and Efficacy of Neramexane in Patients With Moderate to Severe Alzheimer's Disease
A Phase 3 study testing Neramexane in people with Alzheimer's Disease, run by Forest Laboratories at 34 sites in United States.
Trial summary
Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between nerve cells through interaction with a certain type of receptor (N-methyl-D-aspartate, NMDA) on the cell. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Neramexane
- How many people
- 400 participants
- Where
- 34 sitesUnited States
- Study dates
- Mar 2003to Mar 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of moderate to severe Alzheimer's disease;
- ambulatory patients
Who cannot join
- folate deficiency;
- clinically significant central nervous system disease other than Alzheimer's disease;
- clinically significant pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Upstate Clinical Research
Albany, New York, 12205
Medical University of South Carolina
Charleston, South Carolina, 29406
Ohio State University
Columbus, Ohio, 443210
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Mood and Memory Clinic of Michigan
Farmington Hills, Michigan, 48334
Baumel-Eisner Neuromedical Institute
Fort Lauderdale, Florida, 33321
Margolin Brain Institute
Fresno, California, 93720
Berma Research Group
Hialeah, Florida, 33016
Indiana Universisty Medical Center
Indianapolis, Indiana, 46202
Alzheimer's Research Corporation
Lakehurst, New Jersey, 08733
Lexington Clinic
Lexington, Kentucky, 40504
Joel Ross, MD
Long Branch, New Jersey, 07740
Pioneer Pharmaceutical Research
Midvale, Utah, 84047
Yale University School of Medicine
New Haven, Connecticut, 06510
Pharmacology Research Institute
Northridge, California, 91324
UCI Medical Center
Orange, California, 92868
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, 10962
Palm Beach Neurological Center
Palm Beach Gardens, Florida, 33410
Pivotal Research Centers
Peoria, Arizona, 85381
21st Century Neurology
Phoenix, Arizona, 85013
Ubhc/Umdnj
Piscataway, New Jersey, 08855
Neurology Clinical Research, Inc.
Plantation, Florida, 33324
Summit Research Network
Portland, Oregon, 97223
Monroe Community Hospital
Rochester, New York, 14620
Pacific Research Network
San Diego, California, 92103
Affiliated Research Institute
San Diego, California, 92108
J. Gary Booker, MD
Shreveport, Louisiana, 71101
St. Louis University
St Louis, Missouri, 63104
Behavioral Medical Research of Saten Island, PC
Staten Island, New York, 10305
University of South Florida
Tampa, Florida, 33612
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, 43623
Palm Beach Neurology
West Palm Beach, Florida, 33407
North Texas Neurology Research
Wichita, Texas, 76301
Piedmont Medical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind,Placebo-Controlled Evaluation of the Safety and Efficacy of Neramexane Monotherapy in Patients With Moderate to Severe Dementia of the Alzheimer's Type
Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between nerve cells through interaction with a certain type of receptor (N-methyl-D-aspartate, NMDA) on the cell. Neramexane is a new drug that blocks the effects of excessive glutamate at the receptor (NMDA receptor antagonist).
- Conditions
- Alzheimer's Disease
- Being tested
- Neramexane
- Keywords
- Neramexane, NMDA receptor antagonist, Memory Loss, Alzheimer Disease
- Medical subject headings
- Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeramexaneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2004 (estimated)
- Study startMar 2003
- Primary completionMar 2005
- Study completionMar 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090116
- Sponsor's protocol ID
- NER-MD-02
- Status last verified
- Mar 2012
- First submitted
- 24 Aug 2004
- Last updated
- 5 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind,Placebo-Controlled Evaluation of the Safety and Efficacy of Neramexane Monotherapy in Patients With Moderate to Severe Dementia of the Alzheimer's Type
- ClinicalTrials.gov ID
- NCT00090116
- Acronym / sponsor ID
- NER-MD-02
- Conditions
- Alzheimer's Disease
- Keywords
- Neramexane, NMDA receptor antagonist, Memory Loss, Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 26 Aug 2004 (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.
Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between nerve cells through interaction with a certain type of receptor (N-methyl-D-aspartate, NMDA) on the cell. Neramexane is a new drug that blocks the effects of excessive glutamate at the receptor (NMDA receptor antagonist).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of moderate to severe Alzheimer's disease;
- ambulatory patients
Key exclusion criteria (3 listed)
- folate deficiency;
- clinically significant central nervous system disease other than Alzheimer's disease;
- clinically significant pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease
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 |
|---|---|---|
| Neramexane | Drug | – |
Primary outcome
Not reported in the source record.
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 5 Mar 2012.
- Related InfoLink provided by the sponsor.
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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.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neramexane in people with Alzheimer's Disease, run by Forest Laboratories at 34 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 2 inclusion and 3 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 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 5 Mar 2012.