Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease

Study Overview
=================
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.

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

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: MEM 1003
* Drug: MEM 1003
* Drug: Placebo for MEM 1003


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Active 30 mg MEM 1003 | Drug: MEM 1003<br>* 30 mg twice a day<br>|
| Experimental: B<br>90 mg MEM 1003 | Drug: MEM 1003<br>* 90 mg MEM 1003 twice a day<br>|
| Placebo Comparator: C<br>Placebo for MEM 1003 | Drug: Placebo for MEM 1003<br>* Placebo twice a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function |  | Change from baseline at wk 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other Cognitive Assessments, activities of daily living, functional assessments and safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognition, Alzheimer's, Cognitive impairment