Back to resultsEfficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CX516
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Memory Loss, Alzheimer's Disease, Brain Aging, Ampalex®, CX516
Eligibility Criteria
Inclusion criteria Clinical diagnosis of mild cognitive impairment Good general health with no additional diseases that would interfere with the study. Exclusion criteria Any significant neurologic disease (other than suspected incipient Alzheimer's disease), such as Parkinson's disease, stroke, TIA's, multi-infarct dementia, Huntington's disease, head trauma, chronic CNS infection. History of major depression or another major psychiatric disorder within the past 6 months. History of schizophrenia, mania or recurrent psychotic episodes. History of alcohol or DSM IV-diagnosed substance abuse or dependence disorder within the past year. History of blackout, epilepsy or seizures, or an abnormal EEG as judged by the Investigator and considering the age of the participant. Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or hematological illness or unstable medical condition which could interfere with drug safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.
Sites / Locations
- Pivotal Research Centers
- University of California Irvine
- University of California at Los Angeles
- University of California, San Diego
- Yale University School of Medicine
- Sun Coast Gerontology Center, University of South Florida
- Mercy Mayo Clinic
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CX516
Placebo
Arm Description
CX516 - 900 mg
Placebo
Outcomes
Primary Outcome Measures
15-Item Word List Delayed Recall
The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI.
The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00040443
Brief Title
Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
Official Title
Efficacy And Safety Of CX516 (900 mg t.i.d.) In Elderly Participants With Mild Cognitive Impairment. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 4-week Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RespireRx
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is evidence CX516 enhances brain activity by specifically targeting remaining glutamate receptors in the affected portions of the brain. This study will test the safety and efficacy of CX516 in the symptomatic treatment of participants with mild cognitive impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Memory Loss, Alzheimer's Disease, Brain Aging, Ampalex®, CX516
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CX516
Arm Type
Experimental
Arm Description
CX516 - 900 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
CX516
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
15-Item Word List Delayed Recall
Description
The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI.
The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled.
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Clinical diagnosis of mild cognitive impairment
Good general health with no additional diseases that would interfere with the study.
Exclusion criteria
Any significant neurologic disease (other than suspected incipient Alzheimer's disease), such as Parkinson's disease, stroke, TIA's, multi-infarct dementia, Huntington's disease, head trauma, chronic CNS infection.
History of major depression or another major psychiatric disorder within the past 6 months.
History of schizophrenia, mania or recurrent psychotic episodes.
History of alcohol or DSM IV-diagnosed substance abuse or dependence disorder within the past year.
History of blackout, epilepsy or seizures, or an abnormal EEG as judged by the Investigator and considering the age of the participant.
Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or hematological illness or unstable medical condition which could interfere with drug safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.
Facility Information:
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Sun Coast Gerontology Center, University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Mercy Mayo Clinic
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
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