Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT01058941|
Recruitment Status : Completed
First Posted : January 29, 2010
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Lipoic acid and fish oil concentrate Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Lipoic Acid and Omega-3 Fatty Acids in Alzheimer's Disease|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Lipoic acid and Omega-3 fatty acids
Three 1-gram fish oil capsules per day (2 capsules in the morning and 1 capsule in the evening) plus two lipoic acid (LA) capsules per day in the morning. Total daily dose of study drug: 675 mg DHA, 975 mg EPA, 600 mg LA.
Drug: Lipoic acid and fish oil concentrate
Lipoic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months
Placebo Comparator: Placebo
Three placebo oil capsules per day (2 capsules in the morning and 1 capsule in the evening) plus two placebo LA capsules per day in the morning.
Placebo LA and placebo oil capsules for 18 months
Other Name: Placebo for lipoic acid and fish oil concentrate
- Change From Baseline in Activities of Daily Living (ADL) at 18 Months [ Time Frame: Baseline and 18 months ]The Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL) is used to assess activities of daily living in people with AD using a structured interview to ask the AD participant's caregiver/study partner to assess functional ability over a wide range of performance measures. A higher ADL score indicates greater impairment in functional ability; scores range from 0 to 27.
- Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 18 Months [ Time Frame: Baseline and 18 months ]The ADAS-cog assesses general cognitive function over multiple domains and evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates greater impairment on a range of scores from 0 to 70. A total score of 70 indicates maximum severity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058941
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Lynne Shinto, ND, MPH||Oregon Health and Science University|