Phase 2
N=67
Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01058941 ↗Enrolled (actual)
67
Serious AEs
25.4%
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline in Activities of Daily Living (ADL) at 18 Months — -11.58; -13.45 units on a scale — p=0.82
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lipoic acid and fish oil concentrate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Activities of Daily Living (ADL) at 18 Months |
-11.58; -13.45 | 0.82 |
| PRIMARY Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 18 Months |
6.61; 3.40 | 0.001 sig |
Summary
The purpose of this study was to see if taking lipoic acid plus omega-3 fatty acids (omega-3s) can slow the Alzheimer's disease (AD) process. To see if the treatment can slow the AD process, the investigators looked at changes in memory and changes in a person's daily activities over 18 months.
Eligibility Criteria
Inclusion Criteria
- 55 years or older
- Probable AD by National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association - NINCDS/ADRDA criteria
- MMSE between 15-26
- Caregiver/study partner that can accompany participant to all study visits
- Stable use of cholinesterase inhibitors and memantine permitted - doses must be stable for 4 months prior to study enrollment
- Stable doses of over-the-counter antioxidants (e.g. vitamin E, ginkgo biloba) are permitted - dose must be stable for 4 months prior to study enrollment
- Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment
- Geriatric Depression Scale (GDS) - Score of 6 months after diagnosis)
- Health conditions such as cancer diagnosed 500 mg/dl, LDL > 160 mg/dl, total cholesterol >240 mg/dl). LDL levels between 160 mg/dl and 165 mg/dl will be reviewed by the PI and included if judged to be safe. Patients who have a history or hyperlipidemia, but are not taking lipid-lowering medications due to potential memory impairment side effects will be reviewed on a case-by-case basis by the PI and enrolled in the study if deemed safe by PI and the patient's primary care provider.
- Fish intake of one 6 ounce serving > once a week less than 4 months prior to enrollment
- Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil, or flaxseed oil) less than 4 months prior to enrollment
- Lipoic Acid supplementation less than 1 month prior to enrollment
- Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and narcotic analgesics. Certain low dose antipsychotic use will be reviewed by the principle investigator on a case-by-case basis and may be allowed if determined that dose is not strong enough to affect performance on cognitive evaluations. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
- Contraindications to MRI (for subjects enrolled at Bend, Medford, and Klamath sites that decide not to undergo MRI, this will not be an exclusion).
- Enrollment in another study
Data sourced from ClinicalTrials.gov (NCT01058941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.