DHA (Docosahexaenoic Acid), an Omega 3 Fatty Acid, in Slowing the Progression of Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: DHA (Docosahexaenoic Acid); Placebo
Intervention description: 950 mg soft-gel capsules which contain approximately 510 mg DHA, 2 capsules twice a day for 18 months; 2 placebo capsules twice a day for 18 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 402.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: fish oil; omega-3 fatty acids; EPA

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).
    

Eligibility criteria:

        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)