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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
Sponsor:
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: Lipoic acid and fish oil concentrate
Drug: Placebo
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo
Hide Arm/Group Description

lipoic acid and fish oil concentrate

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

placebo lipoic acid plus placebo oil

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

Period Title: Overall Study
Started 34 33
Completed 25 22
Not Completed 9 11
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo Total
Hide Arm/Group Description

lipoic acid and fish oil concentrate

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

placebo lipoic acid plus placebo oil

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

Total of all reporting groups
Overall Number of Baseline Participants 34 33 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  14.7%
4
  12.1%
9
  13.4%
>=65 years
29
  85.3%
29
  87.9%
58
  86.6%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 33 participants 67 participants
73.3
(56 to 92)
76.2
(52 to 89)
74.7
(52 to 92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
Female
18
  52.9%
17
  51.5%
35
  52.2%
Male
16
  47.1%
16
  48.5%
32
  47.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
34
 100.0%
32
  97.0%
66
  98.5%
Unknown or Not Reported
0
   0.0%
1
   3.0%
1
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
American Indian or Alaska Native
0
   0.0%
1
   3.0%
1
   1.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.9%
1
   3.0%
2
   3.0%
White
33
  97.1%
30
  90.9%
63
  94.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.0%
1
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 33 participants 67 participants
34 33 67
1.Primary Outcome
Title Change From Baseline in Activities of Daily Living (ADL) at 18 Months
Hide Description 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.
Time Frame Baseline and 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Twenty participants discontinued from the study prior to completing all study visits. One treatment participant did not complete the final ADL assessment.
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

lipoic acid and fish oil concentrate

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

placebo lipoic acid plus placebo oil

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.58  (12.68) -13.45  (12.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lipoic Acid and Omega-3 Fatty Acids, Placebo
Comments The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments We used a significance level of p = 0.025 for our measure of ADL changes based on a simple Bonferroni adjustment since we have two primary outcomes.
Method Mixed Models Analysis
Comments Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-3.97 to 3.13
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 18 Months
Hide Description 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.
Time Frame Baseline and 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Twenty participants discontinued from the study prior to completing all study visits. One placebo and one treatment participant did not complete the final ADAS-cog assessment.
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

lipoic acid and fish oil concentrate

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

placebo lipoic acid plus placebo oil

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

Overall Number of Participants Analyzed 24 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.61  (6.67) 3.40  (4.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lipoic Acid and Omega-3 Fatty Acids, Placebo
Comments The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments We used a significance level of p = 0.025 for our measure of ADAS-cog changes based on a simple Bonferroni adjustment since we have two primary outcomes.
Method Mixed Models Analysis
Comments Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.68
Confidence Interval (2-Sided) 95%
-5.90 to -1.46
Estimation Comments [Not Specified]
Time Frame Adverse events (AEs) were monitored once a month as a part of the clinic visits and monthly by phone. Reported AEs include events that occurred on or after Day 0 and on or before month 18.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lipoic Acid and Omega-3 Fatty Acids Placebo
Hide Arm/Group Description

lipoic acid and fish oil concentrate

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

placebo lipoic acid plus placebo oil

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months

All-Cause Mortality
Lipoic Acid and Omega-3 Fatty Acids Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/34 (2.94%)      2/33 (6.06%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lipoic Acid and Omega-3 Fatty Acids Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/34 (29.41%)      7/33 (21.21%)    
Cardiac disorders     
Tachycardia  1  1/34 (2.94%)  1 0/33 (0.00%)  0
Atrial fibrillation  1  1/34 (2.94%)  1 0/33 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal obstruction  1  1/34 (2.94%)  1 0/33 (0.00%)  0
Gastric ulcer haemorrhage  1  1/34 (2.94%)  1 0/33 (0.00%)  0
General disorders     
Medical device complication  1  1/34 (2.94%)  1 0/33 (0.00%)  0
Infections and infestations     
Pneumonia  1  1/34 (2.94%)  1 0/33 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1 [1]  0/34 (0.00%)  0 1/33 (3.03%)  1
Head injury  1  1/34 (2.94%)  1 0/33 (0.00%)  0
Metabolism and nutrition disorders     
Abnormal loss of weight  1  1/34 (2.94%)  1 0/33 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Leukaemia  1  0/34 (0.00%)  0 1/33 (3.03%)  1
Laryngeal cancer  1  0/34 (0.00%)  0 1/33 (3.03%)  1
Nervous system disorders     
Dementia Alzheimer's Type  1 [2]  2/34 (5.88%)  2 0/33 (0.00%)  0
Thrombotic cerebral infarction  1  0/34 (0.00%)  0 1/33 (3.03%)  1
Cerebrovascular accident  1  1/34 (2.94%)  1 1/33 (3.03%)  1
Psychiatric disorders     
Drug-induced delirium  1 [3]  0/34 (0.00%)  0 1/33 (3.03%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/34 (0.00%)  0 1/33 (3.03%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory tract infection  1  0/34 (0.00%)  0 1/33 (3.03%)  1
Pleural effusion  1  1/34 (2.94%)  1 0/33 (0.00%)  0
Surgical and medical procedures     
Subdural haematoma evacuation  1  1/34 (2.94%)  1 0/33 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
[1]
Fall down stairs
[2]
Rapid cognitive decline
[3]
Nyquil use
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lipoic Acid and Omega-3 Fatty Acids Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/34 (85.29%)      27/33 (81.82%)    
Blood and lymphatic system disorders     
Anemia  1  2/34 (5.88%)  2 3/33 (9.09%)  3
Gastrointestinal disorders     
Nausea  1  4/34 (11.76%)  6 5/33 (15.15%)  6
Diarrhea  1  1/34 (2.94%)  1 7/33 (21.21%)  8
Vomiting  1  3/34 (8.82%)  4 3/33 (9.09%)  4
Abdominal pain  1  3/34 (8.82%)  3 2/33 (6.06%)  2
General disorders     
Fatigue  1  4/34 (11.76%)  4 1/33 (3.03%)  1
Immune system disorders     
Allergic conditions  1  4/34 (11.76%)  4 0/33 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  4/34 (11.76%)  4 3/33 (9.09%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/34 (2.94%)  1 4/33 (12.12%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer  1  2/34 (5.88%)  3 3/33 (9.09%)  4
Nervous system disorders     
Dizziness  1  3/34 (8.82%)  3 4/33 (12.12%)  4
Headache/Migraine  1  5/34 (14.71%)  6 0/33 (0.00%)  0
Psychiatric disorders     
Depression  1  2/34 (5.88%)  2 3/33 (9.09%)  3
Behavioral and psychiatric symptoms of dementia  1  4/34 (11.76%)  5 0/33 (0.00%)  0
Renal and urinary disorders     
Urinary tract infection  1  1/34 (2.94%)  1 2/33 (6.06%)  3
Urinary incontinence  1  2/34 (5.88%)  2 2/33 (6.06%)  2
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection  1  5/34 (14.71%)  7 7/33 (21.21%)  7
Vascular disorders     
Sycope  1  2/34 (5.88%)  3 1/33 (3.03%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Lynne Shinto, ND, MPH
Organization: Oregon Health & Science University
Phone: 503-494-5035
Responsible Party: Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01058941     History of Changes
Other Study ID Numbers: R01AG033613-01A1 ( U.S. NIH Grant/Contract )
First Submitted: January 27, 2010
First Posted: January 29, 2010
Results First Submitted: March 1, 2017
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017