Clinical trial NCT00257673: Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Cognition
Alzheimer's
Cognitive impairment
Lead sponsor: Memory Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-11-23
Enrollment: 183
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Cognitive function
timeFrame: Change from baseline at wk 12
Secondary outcomes:
measure: Other Cognitive Assessments, activities of daily living, functional assessments and safety
Other outcomes:
Locations:
city: Northport
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: El Centro
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Torrence
country: United States
state: California
city: Hamden
country: United States
state: Connecticut
city: Washington, DC
country: United States
state: District of Columbia
city: Brooksville
country: United States
state: Florida
city: Chiefland
country: United States
state: Florida
city: Coral Springs
country: United States
state: Florida
city: Deerfield Beach
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Hallandale Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Towson
country: United States
state: Maryland
city: Fall River
country: United States
state: Massachusetts
city: St Loius
country: United States
state: Missouri
city: Berlin
country: United States
state: New Jersey
city: Long Branch
country: United States
state: New Jersey
city: Princeton
country: United States
state: New Jersey
city: Ridgewood
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Morganton
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Colmar
country: United States
state: Pennsylvania
city: Media
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Spartanburg
country: United States
state: South Carolina
city: Johnson City
country: United States
state: Tennessee
city: Bedford
country: United States
state: Texas
city: Bulverde
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Midvale
country: United States
state: Utah
city: Bennington
country: United States
state: Vermont
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Memory Pharmaceutical Corp.
name: Stephen Murray, MD, PhD
role: STUDY_DIRECTOR
References: