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

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ClinicalTrials.gov Identifier: NCT00440050
Recruitment Status : Completed
First Posted : February 26, 2007
Results First Posted : August 30, 2010
Last Update Posted : September 25, 2014
Sponsor:
Collaborators:
National Institute on Aging (NIA)
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)

Tracking Information
First Submitted Date  ICMJE February 22, 2007
First Posted Date  ICMJE February 26, 2007
Results First Submitted Date  ICMJE May 28, 2010
Results First Posted Date  ICMJE August 30, 2010
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE February 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2010)
  • Rate of Change on the ADAS-Cog 11. [ Time Frame: 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.
  • Rate of Change on CDR-SOB [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2007)
Changes in rate of cognitive and functional decline measured by ADAS-Cog and CDR-SOB
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2010)
  • ADCS-ADL [ Time Frame: 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.
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease
Official Title  ICMJE A Randomized Double-Blind Placebo-Controlled Trial Of The Effects Of Docosahexaenoic Acid (DHA) In Slowing The Progression Of Alzheimer's Disease
Brief Summary The purpose of this study is to determine whether chronic DHA (Docosahexaenoic Acid) supplementation slows the progression of cognitive and functional decline in mild to moderate Alzheimer's disease (AD).
Detailed Description

Preliminary studies have shown a reduced risk of Alzheimer's disease (AD) in people consuming increased amounts of fish in their diets. Many of the health benefits of fish are attributed to the abundance of omega 3 fatty acids. Docosahexaenoic Acid (DHA) is the most abundant omega 3 fatty acid in the brain. Data from several animal models supports the hypothesis that DHA may be an effective treatment for AD by means of anti-amyloid, antioxidant, and neuroprotectant mechanisms.

In this study, 400 individuals with mild to moderate AD will participate at approximately 53 study sites throughout the US for 18 months. Participants will be randomized so that 60% will receive approximately 2 grams of DHA, divided into 4 capsules, 2 capsules taken twice a day, while 40% receive an identical placebo.

Potential participants will go to their study site for a screening visit, where eligibility is determined, and if accepted, for a baseline visit where cognitive status, behavioral status, functional status, and global severity of dementia will be assessed. Vital signs and biomarker labs will also be obtained. Subsequent visits will occur every three months for medication checks and, every 6 months, further assessments, physical exams, and labs.

Some participants will also take part in MRI (magnetic resonance imaging) and/or CSF (cerebrospinal fluid) sub-studies. For the MRI sub-study, scans will be done prior to beginning the study medication, and again after 18 months. Likewise, for the CSF sub-study, a lumbar puncture will be done prior to beginning the study medication, and again after 18 months.

Enrollment is restricted to individuals who consume no more than 200 mg of DHA per day, which is almost 300% of the average daily intake in an American diet. Individuals who take fish oil or omega 3 fatty acid supplements are also not eligible. Each visit will include completion of a very brief food frequency questionnaire to monitor dietary DHA levels.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: DHA (Docosahexaenoic Acid)
    950 mg soft-gel capsules which contain approximately 510 mg DHA, 2 capsules twice a day for 18 months
    Other Name: Neuromins
  • Drug: Placebo
    2 placebo capsules twice a day for 18 months
Study Arms  ICMJE
  • Experimental: 1.
    DHA
    Intervention: Drug: DHA (Docosahexaenoic Acid)
  • Placebo Comparator: 2.
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2010)
402
Original Enrollment  ICMJE
 (submitted: February 22, 2007)
400
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female
  • 50 years of age or older
  • Residing in the community at baseline (includes assisted living facilities, but excludes long-term care nursing facilities)
  • MMSE (Mini-Mental State Examination) at screen of 14-26 (inclusive)
  • No medical contraindications to study participation
  • Fluent in English or Spanish
  • Corrected vision and hearing sufficient for compliance with testing procedures
  • Supervision available for study medication
  • Caregiver/study partner to accompany participant to all visits
  • Study partner must have direct contact with the participant more than 2 days/week
  • Able to ingest oral medication
  • Daily DHA consumption less than or equal to 200 mg/day in prior two months estimated by an abbreviated DHA food frequency questionnaire
  • Neuroimaging consistent with the diagnosis of AD at some time after the onset of the memory decline
  • Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the investigator
  • Stable use of cholinesterase inhibitors and memantine is permitted if doses are stable for 4 months prior to enrollment

Exclusion Criteria:

  • Non-AD dementia
  • Residence in a long-term care facility at baseline
  • History of clinically significant stroke
  • Modified Hachinski Ischemia score ≥ 4
  • Current evidence or history in past two years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
  • Sensory impairment which would prevent subject from participating in or cooperating with the protocol
  • Use of another investigational agent within two months
  • Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational new drug including clinically significant or unstable hematologic, hepatic, cardiovascular (including history of ventricular fibrillation or ventricular tachycardia), pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality
  • Active neoplastic disease (skin tumors other than melanoma may be included; participants with stable prostate cancer may be included at the discretion of the Project Director)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00440050
Other Study ID Numbers  ICMJE IA0099
1RC2AG036535 ( U.S. NIH Grant/Contract )
ADC-027-DHA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alzheimer's Disease Cooperative Study (ADCS)
Study Sponsor  ICMJE Alzheimer's Disease Cooperative Study (ADCS)
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • DSM Nutritional Products, Inc.
Investigators  ICMJE
Principal Investigator: Joseph Quinn, MD Oregon Health and Science University
PRS Account Alzheimer's Disease Cooperative Study (ADCS)
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP