Trial Outcomes & Findings for Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention (NCT NCT01780974)

Last Updated: 2017-04-07

Results Overview

The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

42 participants

Primary outcome timeframe

Baseline, 6 months, and 12 months

Results posted on

2017-04-07

Participant Flow

Med exclusions included Omega-3 fatty acid supplement intake \< 4 months prior to enrollment; Lipoic acid supplementation \< 1 month prior to enrollment; stable dosage for 4 months prior to enrollment of antihypertensive medication and (if prescribed) lipid lowering medication. Other exclusions included labs and test scores out of range.

Participant milestones

Participant milestones
Measure	Placebo Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate	Lipoic Acid Plus Omega-3 Fatty Acids Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
Overall Study STARTED	21	21
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate	Lipoic Acid Plus Omega-3 Fatty Acids Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
Overall Study Death	1	0
Overall Study Adverse Event	1	3

Baseline Characteristics

Apo E data for 2 participants missing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=21 Participants Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate	Lipoic Acid Plus Omega-3 Fatty Acids n=21 Participants Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate	Total n=42 Participants Total of all reporting groups
Education Completed college	5 Participants n=21 Participants	7 Participants n=21 Participants	12 Participants n=42 Participants
Education Masters/Graduate School	10 Participants n=21 Participants	11 Participants n=21 Participants	21 Participants n=42 Participants
Apo E4 Carrier Yes	5 Participants n=20 Participants • Apo E data for 2 participants missing	7 Participants n=20 Participants • Apo E data for 2 participants missing	12 Participants n=40 Participants • Apo E data for 2 participants missing
Age, Continuous	66.05 years STANDARD_DEVIATION 8.19 • n=21 Participants	65.38 years STANDARD_DEVIATION 5.84 • n=21 Participants	65.71 years STANDARD_DEVIATION 7.03 • n=42 Participants
Sex: Female, Male Female	17 Participants n=21 Participants	10 Participants n=21 Participants	27 Participants n=42 Participants
Sex: Female, Male Male	4 Participants n=21 Participants	11 Participants n=21 Participants	15 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=21 Participants	2 Participants n=21 Participants	3 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=21 Participants	19 Participants n=21 Participants	39 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=21 Participants	1 Participants n=21 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=21 Participants	1 Participants n=21 Participants	1 Participants n=42 Participants
Race (NIH/OMB) White	20 Participants n=21 Participants	18 Participants n=21 Participants	38 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=21 Participants	1 Participants n=21 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=21 Participants	0 Participants n=21 Participants	1 Participants n=42 Participants
Education High school or less	4 Participants n=21 Participants	1 Participants n=21 Participants	5 Participants n=42 Participants
Education Some college	2 Participants n=21 Participants	2 Participants n=21 Participants	4 Participants n=42 Participants
Apo E4 Carrier No	15 Participants n=20 Participants • Apo E data for 2 participants missing	13 Participants n=20 Participants • Apo E data for 2 participants missing	28 Participants n=40 Participants • Apo E data for 2 participants missing
Systolic BP	131.76 mmHg STANDARD_DEVIATION 15.77 • n=21 Participants	141.67 mmHg STANDARD_DEVIATION 14.64 • n=21 Participants	136.71 mmHg STANDARD_DEVIATION 15.84 • n=42 Participants
Diastolic BP	74.29 mmHg STANDARD_DEVIATION 10.79 • n=21 Participants	77.05 mmHg STANDARD_DEVIATION 9.76 • n=21 Participants	75.67 mmHg STANDARD_DEVIATION 10.26 • n=42 Participants
Exercise Doesn't exercise	3 Participants n=19 Participants • Demographic information form missing for 3 participants	2 Participants n=20 Participants • Demographic information form missing for 3 participants	5 Participants n=39 Participants • Demographic information form missing for 3 participants
Exercise Some exercise	2 Participants n=19 Participants • Demographic information form missing for 3 participants	3 Participants n=20 Participants • Demographic information form missing for 3 participants	5 Participants n=39 Participants • Demographic information form missing for 3 participants
Exercise Exercises 2+ times/week	14 Participants n=19 Participants • Demographic information form missing for 3 participants	15 Participants n=20 Participants • Demographic information form missing for 3 participants	29 Participants n=39 Participants • Demographic information form missing for 3 participants
Smoking Non-smoker	10 Participants n=20 Participants • Demographic information missing for 2 participants	11 Participants n=20 Participants • Demographic information missing for 2 participants	21 Participants n=40 Participants • Demographic information missing for 2 participants
Smoking Former smoker	10 Participants n=20 Participants • Demographic information missing for 2 participants	9 Participants n=20 Participants • Demographic information missing for 2 participants	19 Participants n=40 Participants • Demographic information missing for 2 participants
Smoking Smoker	0 Participants n=20 Participants • Demographic information missing for 2 participants	0 Participants n=20 Participants • Demographic information missing for 2 participants	0 Participants n=40 Participants • Demographic information missing for 2 participants
Arachidonic Acid (AA)	9.33 % composition of blood STANDARD_DEVIATION 1.40 • n=21 Participants	10.64 % composition of blood STANDARD_DEVIATION 1.56 • n=21 Participants	9.98 % composition of blood STANDARD_DEVIATION 1.61 • n=42 Participants
Eicosapentaenoic Acid (EPA)	0.84 % composition of blood STANDARD_DEVIATION 0.41 • n=21 Participants	0.62 % composition of blood STANDARD_DEVIATION 0.19 • n=21 Participants	0.73 % composition of blood STANDARD_DEVIATION 0.33 • n=42 Participants
Docosahexaenoic Acid (DHA)	2.62 % composition of blood STANDARD_DEVIATION 1.01 • n=21 Participants	2.53 % composition of blood STANDARD_DEVIATION 0.59 • n=21 Participants	2.58 % composition of blood STANDARD_DEVIATION 0.82 • n=42 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months, and 12 months

Population: Not all tests were completed by all randomized subjects due to missed visits and/or discontinuations.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal. Placebo: placebo capsules	Lipoic Acid Plus Omega-3 Fatty Acids n=21 Participants Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal. Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
Trails Making Test Part B (Executive Function) 6 Months	62.53 time to completion (seconds) Standard Deviation 16.59	69.25 time to completion (seconds) Standard Deviation 20.55
Trails Making Test Part B (Executive Function) 12 Months	69.75 time to completion (seconds) Standard Deviation 20.79	71.10 time to completion (seconds) Standard Deviation 32.77
Trails Making Test Part B (Executive Function) Baseline	69.57 time to completion (seconds) Standard Deviation 19.15	81.59 time to completion (seconds) Standard Deviation 53.08

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: At baseline, 4 participants either could not complete the MRI or the MRI could not be analyzed due to quality; at 12 months, 13 participants either discontinued, could not complete the MRI, or did not complete the baseline and therefore were not scanned.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal. Placebo: placebo capsules	Lipoic Acid Plus Omega-3 Fatty Acids n=21 Participants Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal. Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
White Matter Hyperintensity Volume (Brain MRI) Baseline	6.13 cubic centimeters Standard Deviation 11.91	5.31 cubic centimeters Standard Deviation 7.37
White Matter Hyperintensity Volume (Brain MRI) 12 Months	5.14 cubic centimeters Standard Deviation 13.04	5.07 cubic centimeters Standard Deviation 7.01

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Lipoic Acid Plus Omega-3 Fatty Acids

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=21 participants at risk placebo capsules	Lipoic Acid Plus Omega-3 Fatty Acids n=21 participants at risk Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
Nervous system disorders Benign peripheral position vertigo requiring hospitalization	4.8% 1/21 • Number of events 1 • From baseline to 12 months (end of treatment)	0.00% 0/21 • From baseline to 12 months (end of treatment)
Cardiac disorders Severe angina with worsening symptoms	0.00% 0/21 • From baseline to 12 months (end of treatment)	4.8% 1/21 • Number of events 1 • From baseline to 12 months (end of treatment)
Psychiatric disorders Suicide attempt	4.8% 1/21 • Number of events 1 • From baseline to 12 months (end of treatment)	0.00% 0/21 • From baseline to 12 months (end of treatment)
Cardiac disorders Death from unknown cardiac event	4.8% 1/21 • Number of events 1 • From baseline to 12 months (end of treatment)	0.00% 0/21 • From baseline to 12 months (end of treatment)

Other adverse events

Other adverse events
Measure	Placebo n=21 participants at risk placebo capsules	Lipoic Acid Plus Omega-3 Fatty Acids n=21 participants at risk Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
Gastrointestinal disorders Gastrooesophageal reflux disease	9.5% 2/21 • From baseline to 12 months (end of treatment)	19.0% 4/21 • From baseline to 12 months (end of treatment)
Vascular disorders Dizziness/Vertigo	4.8% 1/21 • From baseline to 12 months (end of treatment)	9.5% 2/21 • From baseline to 12 months (end of treatment)
Musculoskeletal and connective tissue disorders Arm pain	4.8% 1/21 • From baseline to 12 months (end of treatment)	9.5% 2/21 • From baseline to 12 months (end of treatment)
Gastrointestinal disorders Dyspepsia	0.00% 0/21 • From baseline to 12 months (end of treatment)	33.3% 7/21 • From baseline to 12 months (end of treatment)
Musculoskeletal and connective tissue disorders Back pain	9.5% 2/21 • From baseline to 12 months (end of treatment)	4.8% 1/21 • From baseline to 12 months (end of treatment)
Injury, poisoning and procedural complications Fall	9.5% 2/21 • From baseline to 12 months (end of treatment)	0.00% 0/21 • From baseline to 12 months (end of treatment)
Psychiatric disorders Suicidal ideations & behaviors	9.5% 2/21 • From baseline to 12 months (end of treatment)	0.00% 0/21 • From baseline to 12 months (end of treatment)
Injury, poisoning and procedural complications Accident-related injuries	23.8% 5/21 • From baseline to 12 months (end of treatment)	14.3% 3/21 • From baseline to 12 months (end of treatment)
Gastrointestinal disorders Supplement-related difficulties	0.00% 0/21 • From baseline to 12 months (end of treatment)	9.5% 2/21 • From baseline to 12 months (end of treatment)
Respiratory, thoracic and mediastinal disorders Respiratory tract infection	14.3% 3/21 • From baseline to 12 months (end of treatment)	0.00% 0/21 • From baseline to 12 months (end of treatment)
Gastrointestinal disorders Vomiting	9.5% 2/21 • From baseline to 12 months (end of treatment)	9.5% 2/21 • From baseline to 12 months (end of treatment)
Gastrointestinal disorders Nausea	4.8% 1/21 • From baseline to 12 months (end of treatment)	14.3% 3/21 • From baseline to 12 months (end of treatment)
General disorders Fatigue	0.00% 0/21 • From baseline to 12 months (end of treatment)	9.5% 2/21 • From baseline to 12 months (end of treatment)
Surgical and medical procedures Surgery	23.8% 5/21 • From baseline to 12 months (end of treatment)	9.5% 2/21 • From baseline to 12 months (end of treatment)

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