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

This study has been completed.

Sponsor:

Collaborators:

National Institute on Aging (NIA)

DSM Nutritional Products, Inc.

Information provided by (Responsible Party):

Alzheimer's Disease Cooperative Study (ADCS)

ClinicalTrials.gov Identifier:

NCT00440050

First received: February 22, 2007

Last updated: September 15, 2014

Last verified: September 2014

History of Changes

Results First Received: May 28, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Alzheimer's Disease
Interventions:	Drug: DHA (Docosahexaenoic Acid) Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at 51 sites in the United States between February and November 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 555 subjects screened, 402 met the study criteria and were randomized.

Reporting Groups

	Description
Placebo	Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
Docosahexaenoic Acid (DHA)	Dosing of 2 grams of DHA administered in a divided dose twice daily with food.

Participant Flow: Overall Study

	Placebo	Docosahexaenoic Acid (DHA)
STARTED	164	238
COMPLETED	124	171
NOT COMPLETED	40	67

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Placebo	Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
Docosahexaenoic Acid (DHA)	Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Docosahexaenoic Acid (DHA)	Total
Number of Participants [units: participants]	164	238	402
Age [units: years] Mean (Standard Deviation)	76 (9.3)	76 (7.8)	76 (8.7)
Gender [units: participants]
Female	98	112	210
Male	66	126	192
Region of Enrollment [units: participants]
United States	164	238	402

Outcome Measures

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1. Primary:

Rate of Change on the ADAS-Cog 11. [ Time Frame: Baseline, 6, 12, 18 months ]

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Measure Type	Primary
Measure Title	Rate of Change on the ADAS-Cog 11.
Measure Description	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.
Time Frame	Baseline, 6, 12, 18 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Placebo	Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
Docosahexaenoic Acid (DHA)	Dosing of 2 grams of DHA administered in a divided dose twice daily with food.

Measured Values

	Placebo	Docosahexaenoic Acid (DHA)
Number of Participants Analyzed [units: participants]	164	238
Rate of Change on the ADAS-Cog 11. [units: ADAS points per year] Mean (Standard Deviation)	7.98 (9.84)	8.27 (8.9)

No statistical analysis provided for Rate of Change on the ADAS-Cog 11.

2. Primary:

Rate of Change on CDR-SOB [ Time Frame: 18 months ]

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3. Secondary:

ADCS-ADL [ Time Frame: 18 months ]

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4. Secondary:

Neuropsychiatric Inventory (NPI) [ Time Frame: 18 months ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5

Reporting Groups

	Description
Placebo	Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
Docosahexaenoic Acid (DHA)	Dosing of 2 grams of DHA administered in a divided dose twice daily with food.

Other Adverse Events

	Placebo	Docosahexaenoic Acid (DHA)
Total, other (not including serious) adverse events
# participants affected / at risk	144/164 (87.80%)	214/238 (89.92%)
Gastrointestinal disorders
diarrhea ^†
# participants affected / at risk	10/164 (6.10%)	18/238 (7.56%)
# events	10	18
General disorders
dizziness ^†
# participants affected / at risk	9/164 (5.49%)	12/238 (5.04%)
# events	9	12
other ^†
# participants affected / at risk	88/164 (53.66%)	119/238 (50.00%)
# events	88	119
Injury, poisoning and procedural complications
fall ^†
# participants affected / at risk	33/164 (20.12%)	42/238 (17.65%)
# events	33	42
Psychiatric disorders
agitation ^†
# participants affected / at risk	12/164 (7.32%)	24/238 (10.08%)
# events	12	24
Renal and urinary disorders
urinary tract infection ^†
# participants affected / at risk	12/164 (7.32%)	23/238 (9.66%)
# events	12	23

†	Events were collected by systematic assessment

Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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