Clinical trial NCT00090402: Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease
Official title: Fish Oil and Alpha Lipoic Acid in Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alzheimer's Disease
Oxidative Stress
Dementia
Hyperlipidemia
Inflammation
Keywords: Fish Oils
Thioctic Acid
Antioxidants
Dietary Supplements
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Center for Research Resources (NCRR)
First posted: 2004-08-26
Enrollment: 39
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of fish oil and the antioxidant alpha lipoic acid on factors in the blood that are associated with the progression of Alzheimer's Disease (AD).

Detailed description: Alzheimer's disease (AD) is a serious condition associated with increased inflammation, cholesterol, and oxidative stress (a condition involving an excess of free radicals and a decrease in antioxidant levels). Fish oil and alpha lipoic acid, which have few side effects, may help relieve these problems; therefore, these supplements may slow the progression of AD, particularly when given in combination. This study will evaluate the effect of fish oil and alpha lipoic acid on inflammation, lipid levels, and oxidative stress.

Participants in this study will be randomly assigned to receive fish oil alone, fish oil and alpha lipoic acid, or placebo for 1 year. AD rating scales as well as urine and blood tests will be used to assess participants. Participants will have monthly clinic visits during the study to monitor adverse events and to undergo various laboratory tests.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable Alzheimer's Disease or mild cognitive impairment
* Mini Mental State Examination (MMSE) score between 18 and 26
* Clinical Dementia Rating (CDR) of 0.5 or 1.0
* Fluent in English

Exclusion Criteria:

* Use of lipid lowering medications
* Consumption of fish of more than twice a week
* Use of omega and alpha lipoic acid supplements
* Use of systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, or narcotic analgesics
* Depression
* Any other serious health conditions that may interfere with the study
* Enrollment in another clinical trial

Primary outcomes:
measure: F2-isoprostane Level Urine F2-Isoprostanes
timeFrame: baseline, 12 months
measure: Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Lynne H. Shinto, ND
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calon F, Lim GP, Yang F, Morihara T, Teter B, Ubeda O, Rostaing P, Triller A, Salem N Jr, Ashe KH, Frautschy SA, Cole GM. Docosahexaenoic acid protects from dendritic pathology in an Alzheimer's disease mouse model. Neuron. 2004 Sep 2;43(5):633-45. doi: 10.1016/j.neuron.2004.08.013.
citation: Morris MC, Evans DA, Bienias JL, Tangney CC, Bennett DA, Wilson RS, Aggarwal N, Schneider J. Consumption of fish and n-3 fatty acids and risk of incident Alzheimer disease. Arch Neurol. 2003 Jul;60(7):940-6. doi: 10.1001/archneur.60.7.940.
citation: Lovell MA, Xie C, Xiong S, Markesbery WR. Protection against amyloid beta peptide and iron/hydrogen peroxide toxicity by alpha lipoic acid. J Alzheimers Dis. 2003 Jun;5(3):229-39. doi: 10.3233/jad-2003-5306.
citation: Shinto L, Quinn J, Montine T, Dodge HH, Woodward W, Baldauf-Wagner S, Waichunas D, Bumgarner L, Bourdette D, Silbert L, Kaye J. A randomized placebo-controlled pilot trial of omega-3 fatty acids and alpha lipoic acid in Alzheimer's disease. J Alzheimers Dis. 2014;38(1):111-20. doi: 10.3233/JAD-130722.