Alzheimer's DiseasePhase 2NCT00257673
Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing MEM 1003 in people with Alzheimer's Disease, run by Memory Pharmaceuticals at 57 sites in United States.
Trial summary
The purpose of this study is to determine in a 12-week treatment study if MEM 1003 is a safe and effective treatment for patients with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- MEM 1003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 57 sitesUnited States
- Study dates
- Nov 2005to Oct 2007
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- standardized MMSE Score of 10 to 24 points
- diagnosis of probable Alzheimer's disease
- magnetic resonance imaging or computed tomography examination compatible with AD
- modified Hachinski Ischemia Score of less than or equal to 4
- currently receiving no AD therapy or currently receiving donepezil, rivastigmine, or galantamine
Who cannot join
- head injury associated with cognitive impairment
- history of vascular dementia stroke, transient cerebral ischemic episodes, major depression, major psychotic disorder, or symptomatic postural hypotension
- treatment for Alzheimer's disease other than donepezil, rivastigmine, or galantamine; tacrine is not permitted in the last 30 days or memantine in the last 90 days
- treatment with calcium channel blockers or any investigational medications within the prior 30 days
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Study site
Albany, New York, 12208
Study site
Atlanta, Georgia, 30342
Study site
Bedford, Texas, 76021
Study site
Bennington, Vermont, 05201
Study site
Berlin, New Jersey, 08009
Study site
Brooksville, Florida, 34613
Study site
Bulverde, Texas, 78163
Study site
Chicago, Illinois, 60610
Study site
Chiefland, Florida, 32626
Study site
Colmar, Pennsylvania, 18915
Study site
Coral Springs, Florida, 33065
Study site
Decatur, Georgia, 30030
Study site
Deerfield Beach, Florida, 33064
Study site
Delray Beach, Florida, 33445
Study site
El Centro, California, 92243
Study site
Fall River, Massachusetts, 02721
Study site
Hallandale, Florida, 33009
Study site
Hamden, Connecticut, 06518
Study site
Hialeah, Florida, 33016
Study site
Johnson City, Tennessee, 37601
Study site
Long Branch, New Jersey, 07740
Study site
Media, Pennsylvania, 19063
Study site
Mesa, Arizona, 85201
Study site
Miami, Florida, 33137
Study site
Miami, Florida, 33143
Study site
Miami, Florida, 33173
Study site
Midvale, Utah, 84047
Study site
Morganton, North Carolina, 28655
Study site
New Orleans, Louisiana, 70114
Study site
Norfolk, Virginia, 23507
Study site
Northport, Alabama, 35476
Study site
Philadelphia, Pennsylvania, 19149
Study site
Phoenix, Arizona, 85013
Study site
Plantation, Florida, 33317
Study site
Port Charlotte, Florida, 33952
Study site
Portland, Oregon, 97210
Study site
Princeton, New Jersey, 08560
Study site
Ridgewood, New Jersey, 07450
Study site
Riverside, California, 92506
Study site
Saint Loius, Missouri, 63141
Study site
San Antonio, Texas, 78217
Study site
San Francisco, California, 94109
Study site
Sarasota, Florida, 34243
Study site
Shreveport, Louisiana, 71104
Study site
Spartanburg, South Carolina, 29303
Study site
Spokane, Washington, 99204
Study site
St. Petersburg, Florida, 33701
Study site
Staten Island, New York, 10312
Study site
Sun City, Arizona, 85351
Study site
Sunrise, Florida, 33351
Study site
Tampa, Florida, 33609
Study site
Tampa, Florida, 33647
Study site
Toms River, New Jersey, 08755
Study site
Torrence, California, 90505
Study site
Towson, Maryland, 21286
Study site
Washington D.C., District of Columbia, 20007
Study site
West Palm Beach, Florida, 33409
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of MEM 1003 in Patients With Mild to Moderate Alzheimer's Disease
The purpose of this study is to determine in a 12-week treatment study if MEM 1003 is a safe and effective treatment for patients with mild to moderate Alzheimer's disease.
Read the detailed description
Alzheimer's disease is the leading cause of dementia and one of the most common diseases of the aging population. It is a chronic brain disease that involves gradual memory loss, decline in the ability to perform routine tasks, disorientation, difficulty in learning, loss of language skills, impairment of judgment, and personality changes in affected individuals. The neurodegenerative nature of the disease eventually leads to the failure of other organ systems and death.
Perturbations in calcium homeostasis in the central nervous system, such as those associated with Alzheimer's disease and aging as well as stroke and head trauma can result in an increase in intracellular levels of calcium (Ca2+). Increased levels of Ca2+ may lead to cellular dysregulation and cell death. The role of calcium in these neurodegenerative processes led to the hypothesis that controlling calcium levels may be beneficial, particularly where progressive neuronal damage results in cognitive dysfunction and memory loss.
MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel modulators.
- Conditions
- Alzheimer's Disease
- Being tested
- MEM 1003, Placebo for MEM 1003
- Keywords
- Cognition, Alzheimer's, Cognitive impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEM 1003Drug
30 mg twice a day
MEM 1003Drug
90 mg MEM 1003 twice a day
Placebo for MEM 1003Drug
Placebo twice a day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Active 30 mg MEM 1003 Receives: Drug: MEM 1003 |
| B | Experimental | 90 mg MEM 1003 Receives: Drug: MEM 1003 |
| C | Placebo comparator | Placebo for MEM 1003 Receives: Drug: Placebo for MEM 1003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Measured: Change from baseline at wk 12
Secondary outcomes (1)
Other Cognitive Assessments, activities of daily living, functional assessments and safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionOct 2007
- Study completionOct 2007
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memory Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephen Murray, MD, PhD, Study director, Memory Pharmaceutical Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257673
- Sponsor's protocol ID
- MEM 1003-004
- Status last verified
- May 2008
- First submitted
- 22 Nov 2005
- Last updated
- 6 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of MEM 1003 in Patients With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00257673
- Acronym / sponsor ID
- MEM 1003-004
- Conditions
- Alzheimer's Disease
- Keywords
- Cognition, Alzheimer's, Cognitive impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Memory PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Nov 2005 (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.
The purpose of this study is to determine in a 12-week treatment study if MEM 1003 is a safe and effective treatment for patients with mild to moderate Alzheimer's disease.
Detailed description
Alzheimer's disease is the leading cause of dementia and one of the most common diseases of the aging population. It is a chronic brain disease that involves gradual memory loss, decline in the ability to perform routine tasks, disorientation, difficulty in learning, loss of language skills, impairment of judgment, and personality changes in affected individuals. The neurodegenerative nature of the disease eventually leads to the failure of other organ systems and death.
Perturbations in calcium homeostasis in the central nervous system, such as those associated with Alzheimer's disease and aging as well as stroke and head trauma can result in an increase in intracellular levels of calcium (Ca2+). Increased levels of Ca2+ may lead to cellular dysregulation and cell death. The role of calcium in these neurodegenerative processes led to the hypothesis that controlling calcium levels may be beneficial, particularly where progressive neuronal damage results in cognitive dysfunction and memory loss.
MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel modulators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MEM 1003Active 30 mg MEM 1003 |
| B | Experimental | Drug: MEM 100390 mg MEM 1003 |
| C | Placebo comparator | Drug: Placebo for MEM 1003Placebo for MEM 1003 |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- standardized MMSE Score of 10 to 24 points
- diagnosis of probable Alzheimer's disease
- magnetic resonance imaging or computed tomography examination compatible with AD
- modified Hachinski Ischemia Score of less than or equal to 4
- currently receiving no AD therapy or currently receiving donepezil, rivastigmine, or galantamine
Key exclusion criteria (4 listed)
- head injury associated with cognitive impairment
- history of vascular dementia stroke, transient cerebral ischemic episodes, major depression, major psychotic disorder, or symptomatic postural hypotension
- treatment for Alzheimer's disease other than donepezil, rivastigmine, or galantamine; tacrine is not permitted in the last 30 days or memantine in the last 90 days
- treatment with calcium channel blockers or any investigational medications within the prior 30 days
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 |
|---|---|---|
| MEM 100330 mg twice a day | Drug | A |
| MEM 100390 mg MEM 1003 twice a day | Drug | B |
| Placebo for MEM 1003Placebo twice a day | Drug | C |
Primary outcome
Cognitive function
Time frame: Change from baseline at wk 12
1 secondary outcome
Other Cognitive Assessments, activities of daily living, functional assessments and safety
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 6 May 2008.
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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.
Stephen Murray, MD, PhD study director
Memory Pharmaceutical Corp.
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEM 1003 in people with Alzheimer's Disease, run by Memory Pharmaceuticals at 57 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 5 inclusion and 4 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 6 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 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 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?
Cognitive function (time frame: Change from baseline at wk 12). 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 6 May 2008.