Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.

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.

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Drug: Placebo; Drug: CX516

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Pivotal Research Centers
  • California
    • Irvine, California, United States, 92697
      • University of California Irvine
    • Los Angeles, California, United States, 90095
      • University of California at Los Angeles
    • San Diego, California, United States, 92093
      • University of California, San Diego
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • Florida
    • Tampa, Florida, United States, 33617
      • Sun Coast Gerontology Center, University of South Florida
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Mercy Mayo Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo
EXPERIMENTAL: CX516; CX516 - 900 mg	Drug: CX516

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 Days

Collaborators and Investigators

• Sponsor: RespireRx

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (ACTUAL): August 1, 2003
• Study Completion (ACTUAL): June 1, 2004

Study Registration Dates

• First Submitted: June 26, 2002
• First Submitted That Met QC Criteria: June 27, 2002
• First Posted (ESTIMATE): June 28, 2002

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Mild Cognitive Impairment; Memory Loss; Brain Aging; Ampalex®; CX516
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: CORX-CX516-012.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO