Trial · NCT00440050

DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease

NCT00440050, Phase 3, Completed, Alzheimer's Disease Cooperative Study (ADCS); results first posted 2010-08-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease. Trials, record NCT00440050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00440050

On this page

Trial

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

Title: DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease
NCT number: NCT00440050
Status: Completed
Phases: Phase 3
Enrollment: 402 participants, actual
Lead sponsor: Alzheimer's Disease Cooperative Study (ADCS)
Conditions: Alzheimer's Disease
Interventions: DHA (Docosahexaenoic Acid), Placebo
First posted: 2007-02-26
Last updated: 2014-09-25
Results first posted: 2010-08-30

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Rate of Change on the ADAS-Cog 11.	Baseline, 6, 12, 18 months	ADAS-cog 11 = Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year. This is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.
Primary	Rate of Change on CDR-SOB	18 months	CDR-SOB = Clinical Dementia Rating, Sum of Boxes. This is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.
Secondary	ADCS-ADL	18 months	ADCS-ADL = Alzheimer's Disease Cooperative Study Activities of Daily Living Score. This is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 6 with lower numbers indicating greater impairment.
Secondary	Neuropsychiatric Inventory (NPI)	18 months	The Neuropsychiatric Inventory quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, sleep change, appetite change, and others. This is a structured questionnaire administered to the subject's caregiver/study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Rate of Change on the ADAS-Cog 11.	Baseline, 6, 12, 18 months	ADAS points per year	MEAN
PRIMARY	Rate of Change on CDR-SOB	18 months	Units on a scale	MEAN
SECONDARY	ADCS-ADL	18 months	Units on a scale	MEAN
SECONDARY	Neuropsychiatric Inventory (NPI)	18 months	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Rate of Change on the ADAS-Cog 11.	Placebo	7.98	Standard Deviation 9.84	ADAS points per year
Rate of Change on the ADAS-Cog 11.	Docosahexaenoic Acid (DHA)	8.27	Standard Deviation 8.9	ADAS points per year
Rate of Change on CDR-SOB	Placebo	2.87	Standard Deviation 2.93	Units on a scale
Rate of Change on CDR-SOB	Docosahexaenoic Acid (DHA)	2.93	Standard Deviation 2.83	Units on a scale
ADCS-ADL	Placebo	10.43	Standard Deviation 11.74	Units on a scale
ADCS-ADL	Docosahexaenoic Acid (DHA)	11.51	Standard Deviation 13.23	Units on a scale
Neuropsychiatric Inventory (NPI)	Placebo	2.93	Standard Deviation 13.62	Units on a scale
Neuropsychiatric Inventory (NPI)	Docosahexaenoic Acid (DHA)	5.09	Standard Deviation 15.08	Units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	164
Overall Study	STARTED	Docosahexaenoic Acid (DHA)	238
Overall Study	COMPLETED	Placebo	124
Overall Study	COMPLETED	Docosahexaenoic Acid (DHA)	171
Overall Study	NOT COMPLETED	Placebo	40
Overall Study	NOT COMPLETED	Docosahexaenoic Acid (DHA)	67

Source ClinicalTrials.gov

Adverse events18

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	diarrhea	Gastrointestinal disorders	Placebo	10	164	10
other	diarrhea	Gastrointestinal disorders	Docosahexaenoic Acid (DHA)	18	238	18
other	urinary tract infection	Renal and urinary disorders	Placebo	12	164	12
other	urinary tract infection	Renal and urinary disorders	Docosahexaenoic Acid (DHA)	23	238	23
other	fall	Injury, poisoning and procedural complications	Placebo	33	164	33
other	fall	Injury, poisoning and procedural complications	Docosahexaenoic Acid (DHA)	42	238	42
other	dizziness	General disorders	Placebo	9	164	9
other	dizziness	General disorders	Docosahexaenoic Acid (DHA)	12	238	12
other	agitation	Psychiatric disorders	Placebo	12	164	12
other	agitation	Psychiatric disorders	Docosahexaenoic Acid (DHA)	24	238	24

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Docosahexaenoic Acid (DHA)
Total, other adverse events	Placebo	144	164
Total, other adverse events	Docosahexaenoic Acid (DHA)	214	238
Total, serious adverse events	Placebo	50	164
Total, serious adverse events	Docosahexaenoic Acid (DHA)	76	238

Source ClinicalTrials.gov

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
11935973	BACKGROUND	PubMed
12873849	BACKGROUND	PubMed
14745067	BACKGROUND	PubMed
15041028	BACKGROUND	PubMed
15339646	BACKGROUND	PubMed
15788759	BACKGROUND	PubMed
21045096	DERIVED	PubMed
27358067	DERIVED	PubMed
39800465	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
RC2AG036535	Amyloid Imaging, VMCI, and Analysis for ADNI	WEINER, MICHAEL W	NORTHERN CALIFORNIA INSTITUTE/RES/EDU	NATIONAL INSTITUTE ON AGING	2009 to 2010

Source NIH RePORTER

Trial comparisons1

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

Comparison
Docosahexaenoic Acid (DHA) vs Placebo: serious adverse events

Source Trial comparisons

Tests0

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

None in this release.

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/NCT00440050

GET https://conductscience.org/api/trials/v1/NCT00440050/registered

API reference For AI assistants