Mild Cognitive ImpairmentPhase 2NCT00040443
Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
A Phase 2 study testing CX516 in people with Mild Cognitive Impairment, run by RespireRx at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- CX516
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2002to Jun 2004
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of mild cognitive impairment
- Good general health with no additional diseases that would interfere with the study.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Mercy Mayo Clinic
Des Moines, Iowa, 50314
University of California Irvine
Irvine, California, 92697
University of California at Los Angeles
Los Angeles, California, 90095
Yale University School of Medicine
New Haven, Connecticut, 06510
Pivotal Research Centers
Peoria, Arizona, 85381
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California, San Diego
San Diego, California, 92093
Sun Coast Gerontology Center, University of South Florida
Tampa, Florida, 33617
About this study
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.
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- CX516, Placebo
- Keywords
- Mild Cognitive Impairment, Memory Loss, Alzheimer's Disease, Brain Aging, Ampalex®, CX516
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX516Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CX516 | Experimental | CX516 - 900 mg Receives: Drug: CX516 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2002 (estimated)
- Study startApr 2002
- Primary completionAug 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- RespireRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040443
- Sponsor's protocol ID
- CORX-CX516-012.1
- Status last verified
- Oct 2017
- First submitted
- 26 Jun 2002
- Last updated
- 23 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00040443
- Acronym / sponsor ID
- CORX-CX516-012.1
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Memory Loss, Alzheimer's Disease, Brain Aging, Ampalex®, CX516
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- RespireRxIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Aug 2003 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 28 Jun 2002 (estimated)
- Results
- Posted 23 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CX516 | Experimental | Drug: CX516CX516 - 900 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of mild cognitive impairment
- Good general health with no additional diseases that would interfere with the study.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| CX516 | Drug | CX516 |
| Placebo | Drug | Placebo |
Primary outcome
15-Item Word List Delayed Recall
Time frame: 28 Days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 CX516 in people with Mild Cognitive Impairment, run by RespireRx at 8 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 2 inclusion and 6 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 23 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
15-Item Word List Delayed Recall (time frame: 28 Days). 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 23 Jul 2018.