Trial Outcomes & Findings for Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease (NCT NCT00090402)
NCT ID: NCT00090402
Last Updated: 2017-07-21
Results Overview
F2-isoprostane is a biomarker was used as an effective indicator for detecting a decrease in systemic oxidative damage (oxidative damage in lipids). Urine F2-Isoprostanes were used to avoid ex vivo lipid peroxidation that can occur with plasma samples.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
39 participants
Primary outcome timeframe
baseline, 12 months
Results posted on
2017-07-21
Participant Flow
Participant milestones
| Measure |
Fish Oil
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
|
Placebo
Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
|
Fish Oil Plus Lipoic Acid
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
13
|
|
Overall Study
COMPLETED
|
11
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Fish Oil
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
|
Placebo
Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
|
Fish Oil Plus Lipoic Acid
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
0
|
|
Overall Study
subject moved
|
0
|
1
|
0
|
|
Overall Study
stopped taking study medication
|
1
|
0
|
1
|
Baseline Characteristics
Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
|
Fish Oil
n=13 Participants
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
|
Fish Oil Plus Lipoic Acid
n=13 Participants
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Age, Continuous
|
75.2 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
75.9 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
76.7 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
75.9 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
39 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 monthsPopulation: intention to treat (ITT)
F2-isoprostane is a biomarker was used as an effective indicator for detecting a decrease in systemic oxidative damage (oxidative damage in lipids). Urine F2-Isoprostanes were used to avoid ex vivo lipid peroxidation that can occur with plasma samples.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
|
Fish Oil
n=13 Participants
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
|
Fish Oil Plus Lipoic Acid
n=13 Participants
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
|
|---|---|---|---|
|
F2-isoprostane Level Urine F2-Isoprostanes
|
0.40 nanogram per miligram
Standard Deviation 1.10
|
-2.02 nanogram per miligram
Standard Deviation 3.30
|
0.45 nanogram per miligram
Standard Deviation 0.53
|
PRIMARY outcome
Timeframe: baseline, 12 monthsThe MMSE is a measure of global cognitive function, and scores range from 0-30, with a lower score indicates greater cognitive impairment.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
|
Fish Oil
n=11 Participants
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
|
Fish Oil Plus Lipoic Acid
n=12 Participants
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
|
|---|---|---|---|
|
Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months
|
-4.64 units on a scale
Standard Deviation 4.65
|
-4.27 units on a scale
Standard Deviation 4.15
|
-1.00 units on a scale
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: In the placebo group there were 2 discontinuations (1 moved, 1 death). In the fish oil group there were 2 discontinuations (1 discontinue, 1 death). In the fish oil and lipoic acid group there was 1 discontinuation (due to meds). These discontinuations did not complete the study.
The Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) measures an individual's ability to carry out tasks that are important for daily living and capture functional changes. Scores for each question range from 0 (no assistance needed) to 2 (full assistance needed), and were assessed by informant interview. The combination of scores for ADL (ranging from 0-18) and IADL (0-14) is the outcome (0-32), with higher scores indicating lesser ability to carry out daily living tasks.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
|
Fish Oil
n=11 Participants
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
|
Fish Oil Plus Lipoic Acid
n=12 Participants
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
|
|---|---|---|---|
|
Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months
|
4.2 units on a scale
Standard Error 0.9
|
0.7 units on a scale
Standard Error 1.0
|
0.9 units on a scale
Standard Error 1.1
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Fish Oil
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Fish Oil Plus Lipoic Acid
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=13 participants at risk
Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate
|
Fish Oil
n=13 participants at risk
Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.
|
Fish Oil Plus Lipoic Acid
n=13 participants at risk
Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg).
|
|---|---|---|---|
|
Cardiac disorders
Heart Failure
|
0.00%
0/13 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
7.7%
1/13 • Number of events 1 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
0.00%
0/13 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
|
Renal and urinary disorders
Urinary Tract Infection (UTI)
|
7.7%
1/13 • Number of events 1 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
0.00%
0/13 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
0.00%
0/13 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
Other adverse events
| Measure |
Placebo
n=13 participants at risk
Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate
|
Fish Oil
n=13 participants at risk
Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.
|
Fish Oil Plus Lipoic Acid
n=13 participants at risk
Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg).
|
|---|---|---|---|
|
Endocrine disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
15.4%
2/13 • Number of events 2 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
15.4%
2/13 • Number of events 2 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
|
Nervous system disorders
Falls
|
15.4%
2/13 • Number of events 2 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
7.7%
1/13 • Number of events 1 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
0.00%
0/13 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
|
General disorders
cold
|
23.1%
3/13 • Number of events 3 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
15.4%
2/13 • Number of events 2 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
15.4%
2/13 • Number of events 2 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
|
Gastrointestinal disorders
loose stools
|
23.1%
3/13 • Number of events 3 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
0.00%
0/13 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
23.1%
3/13 • Number of events 3 • 12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
|
Additional Information
Lynne Shinto, ND, MPH
Oregon Health & Science University
Phone: 503-494-5035
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place