CompletedPhase 2Results posted

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.

Lead sponsor

RespireRx

Asset

CX516

Listed sites

Recruiting sites

Enrollment

175

actual

Study population

MCI / preclinical Alzheimer’s

Key I/E criterion

•Age 55-85

Primary endpoint

•15-Item Word List Delayed Recall

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCORX-CX516-012.1

NCT IDNCT00040443

Timeline

Milestones

Study start2002-04 (month precision)

Study first posted2002-06-28estimated

Primary completion2003-08actual (month precision)

Study completion2004-06actual (month precision)

Last update posted2018-07-23actual

Results first posted2018-07-23actual

Assets

Drug assets

CX516

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Memory

2 endpoints

Primary/protocol endpoint

15-Item Word List Delayed Recall

Time frame:28 Days

event count, event

Primary/registry result

15-Item Word List Delayed Recall

Time frame:28 Days

event count, event

Posted result

Group	Value (mean), units on a scale - change from baseline	Standard deviation
CX516n=84 Participants	-0.3	2.3
Placebon=91 Participants	-0.5	2.3

Mean Difference (Final Values)5p<.05t-test, 2 sided

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.