Trial · NCT00040443

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

NCT00040443, Phase 2, Completed, RespireRx; results first posted 2018-07-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment. Trials, record NCT00040443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00040443

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
NCT number: NCT00040443
Status: Completed
Phases: Phase 2
Enrollment: 175 participants, actual
Lead sponsor: RespireRx
Conditions: Mild Cognitive Impairment
Interventions: CX516, Placebo
First posted: 2002-06-28
Last updated: 2018-07-23
Results first posted: 2018-07-23

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	15-Item Word List Delayed Recall	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	15-Item Word List Delayed Recall	28 Days	Intent to Treat (ITT)	units on a scale - change from baseline	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
15-Item Word List Delayed Recall	CX516		-0.3	Standard Deviation 2.3	units on a scale - change from baseline
15-Item Word List Delayed Recall	Placebo		-0.5	Standard Deviation 2.3	units on a scale - change from baseline

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CX516	84
Overall Study	STARTED	Placebo	91
Overall Study	COMPLETED	CX516	84
Overall Study	COMPLETED	Placebo	91
Overall Study	NOT COMPLETED	CX516	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal Pain	Gastrointestinal disorders	CX516	4	84	4
other	Abdominal Pain	Gastrointestinal disorders	Placebo	2	91	2
other	Fatigue	General disorders	CX516	6	84	6
other	Fatigue	General disorders	Placebo	4	91	4
other	Urinary Tract Infections	Infections and infestations	CX516	3	84	3
other	Urinary Tract Infections	Infections and infestations	Placebo	0	91	0
other	Creatinin increased	Investigations	CX516	4	84	4
other	Creatinin increased	Investigations	Placebo	1	91	1
other	Arthralgia	Musculoskeletal and connective tissue disorders	CX516	1	84	1
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	4	91	4

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CX516	0	84
Total, all-cause mortality	Placebo	0	91
Total, other adverse events	CX516	68	84
Total, other adverse events	Placebo	56	91
Total, serious adverse events	CX516	3	84
Total, serious adverse events	Placebo	1	91

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
CX516 vs Placebo: deaths from any cause	Trial comparisons
CX516 vs Placebo: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Short Story Recall	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00040443

GET https://conductscience.org/api/trials/v1/NCT00040443/events?page=2

API reference For AI assistants