Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|