Boston University | Alzheimer's Disease Center | Research | Treatment & Prevention

Study Overview

The DHA study evaluates the effectiveness of a new medication, DHA™ (Docosahexaenoic Acid) in slowing the progression of Alzheimer’s disease (AD).

The progressive cognitive decline in AD is thought to be caused by an abnormal build-up of amyloid beta-42 (Aβ-42) in the brains of patients. This study will determine whether DHA can slow this process down and slow the progression of AD.

This study is a federally funded study by the Alzheimer's disease Cooperative Study (ADCS), through a grant from the National Institute on Aging (NIA).

The study is looking for participants diagnosed with mild to moderate AD who have a caregiver who can accompany them to clinic visits.

Who Is Eligible to Participate?

Have mild to moderate AD.
Be 50 years or older.
Able to take oral medication.
Have a reliable caregiver or relative who can accompany the participant to all clinic visits and answer questions about the participant. The caregiver must either live with the volunteer or see him/her at least 2 days per week.
Cholinesterase inhibitors and memantine at stable doses for 4 months prior to enrollment.

Who is Excluded from Participation?

Residence in a long-term care facility at baseline
History of clinically significant stroke
Current or history in past two years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or any major psychiatric disorder.
Use of another investigational agent within two months

What Happens In This Study?

The screening visit and the baseline evaluation (if you qualify) are about 2.5 hours. If you agree to any of the optional tests (e.g. genetic testing, lumbar puncture, MRI), the visit may be a little longer.

Eligible participants with AD will be given either DHA or a placebo (capsules with no active ingredient) twice daily for 18 months. All subjects take the study drug twice a day with food (morning and evening).

There are visits every 3 months. These visits take about 15 minutes to ensure that you are tolerating the study drug well and to provide refills of the study medication. Six monthly visits are longer for tests for about 2.5 hours.

Where Is The Study Taking Place?

Boston University Medical Center. Click here for directions.

How Can I Find Out More?

Please contact Carol Rossi at (617) 414-1198 or cjrossi@bu.edu.

Key Personnel for DHA Study

Anil Nair, MD - Principal Investigator. Email: an@bu.edu

Robert Green, MD MPH - Site P.I. for Boston University for ADCS.

Carol Rossi, RN - Study Coordinator for the DHA study: cjrossi@bu.edu

ClinicalTrials.gov identifier - NCT00440050

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