Trial Outcomes & Findings for Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease (NCT NCT01058941)

Last Updated: 2017-04-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

67 participants

Primary outcome timeframe

Baseline and 18 months

Results posted on

2017-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Lipoic Acid and Omega-3 Fatty Acids 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 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 Study STARTED	34	33
Overall Study COMPLETED	25	22
Overall Study NOT COMPLETED	9	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lipoic Acid and Omega-3 Fatty Acids n=34 Participants 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 n=33 Participants 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 n=67 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
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Age, Continuous	73.3 years n=5 Participants	76.2 years n=7 Participants	74.7 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	33 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 18 months

Population: Twenty participants discontinued from the study prior to completing all study visits. One treatment participant did not complete the final ADL assessment.

Outcome measures

Outcome measures
Measure	Lipoic Acid and Omega-3 Fatty Acids n=24 Participants 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 n=22 Participants 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
Change From Baseline in Activities of Daily Living (ADL) at 18 Months	-11.58 units on a scale Standard Deviation 12.68	-13.45 units on a scale Standard Deviation 12.89

PRIMARY outcome

Timeframe: Baseline and 18 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lipoic Acid and Omega-3 Fatty Acids n=24 Participants 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 n=21 Participants 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
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 18 Months	6.61 units on a scale Standard Deviation 6.67	3.40 units on a scale Standard Deviation 4.50

Adverse Events

Lipoic Acid and Omega-3 Fatty Acids

Serious events: 10 serious events

Other events: 29 other events

Deaths: 1 deaths

Placebo

Serious events: 7 serious events

Other events: 27 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. 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

Measure	Lipoic Acid and Omega-3 Fatty Acids n=34 participants at risk 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 n=33 participants at risk 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
Psychiatric disorders Drug-induced delirium	0.00% 0/34 • 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.	3.0% 1/33 • Number of events 1 • 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.
Nervous system disorders Dementia Alzheimer's Type	5.9% 2/34 • Number of events 2 • 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.	0.00% 0/33 • 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.
Cardiac disorders Tachycardia	2.9% 1/34 • Number of events 1 • 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.	0.00% 0/33 • 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.
Nervous system disorders Thrombotic cerebral infarction	0.00% 0/34 • 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.	3.0% 1/33 • Number of events 1 • 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.
Nervous system disorders Cerebrovascular accident	2.9% 1/34 • Number of events 1 • 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.	3.0% 1/33 • Number of events 1 • 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.
Cardiac disorders Atrial fibrillation	2.9% 1/34 • Number of events 1 • 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.	0.00% 0/33 • 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.
Metabolism and nutrition disorders Abnormal loss of weight	2.9% 1/34 • Number of events 1 • 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.	0.00% 0/33 • 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.
Injury, poisoning and procedural complications Fall	0.00% 0/34 • 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.	3.0% 1/33 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/34 • 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.	3.0% 1/33 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory tract infection	0.00% 0/34 • 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.	3.0% 1/33 • Number of events 1 • 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.
Renal and urinary disorders Acute kidney injury	0.00% 0/34 • 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.	3.0% 1/33 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.9% 1/34 • Number of events 1 • 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.	0.00% 0/33 • 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.
Gastrointestinal disorders Gastrointestinal obstruction	2.9% 1/34 • Number of events 1 • 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.	0.00% 0/33 • 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.
Surgical and medical procedures Subdural haematoma evacuation	2.9% 1/34 • Number of events 1 • 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.	0.00% 0/33 • 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.
Gastrointestinal disorders Gastric ulcer haemorrhage	2.9% 1/34 • Number of events 1 • 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.	0.00% 0/33 • 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.
Injury, poisoning and procedural complications Head injury	2.9% 1/34 • Number of events 1 • 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.	0.00% 0/33 • 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.
General disorders Medical device complication	2.9% 1/34 • Number of events 1 • 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.	0.00% 0/33 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/34 • 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.	3.0% 1/33 • Number of events 1 • 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.
Infections and infestations Pneumonia	2.9% 1/34 • Number of events 1 • 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.	0.00% 0/33 • 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.

Measure	Lipoic Acid and Omega-3 Fatty Acids n=34 participants at risk 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 n=33 participants at risk 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
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	14.7% 5/34 • Number of events 7 • 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.	21.2% 7/33 • Number of events 7 • 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.
Gastrointestinal disorders Nausea	11.8% 4/34 • Number of events 6 • 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.	15.2% 5/33 • Number of events 6 • 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.
Gastrointestinal disorders Diarrhea	2.9% 1/34 • Number of events 1 • 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.	21.2% 7/33 • Number of events 8 • 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.
Gastrointestinal disorders Vomiting	8.8% 3/34 • Number of events 4 • 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.	9.1% 3/33 • Number of events 4 • 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.
Nervous system disorders Dizziness	8.8% 3/34 • Number of events 3 • 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.	12.1% 4/33 • Number of events 4 • 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.
Injury, poisoning and procedural complications Fall	11.8% 4/34 • Number of events 4 • 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.	9.1% 3/33 • Number of events 3 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	5.9% 2/34 • Number of events 3 • 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.	9.1% 3/33 • Number of events 4 • 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.
Nervous system disorders Headache/Migraine	14.7% 5/34 • Number of events 6 • 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.	0.00% 0/33 • 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.
Blood and lymphatic system disorders Anemia	5.9% 2/34 • Number of events 2 • 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.	9.1% 3/33 • Number of events 3 • 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.
Psychiatric disorders Depression	5.9% 2/34 • Number of events 2 • 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.	9.1% 3/33 • Number of events 3 • 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.
Psychiatric disorders Behavioral and psychiatric symptoms of dementia	11.8% 4/34 • Number of events 5 • 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.	0.00% 0/33 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 1/34 • Number of events 1 • 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.	12.1% 4/33 • Number of events 4 • 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.
General disorders Fatigue	11.8% 4/34 • Number of events 4 • 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.	3.0% 1/33 • Number of events 1 • 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.
Immune system disorders Allergic conditions	11.8% 4/34 • Number of events 4 • 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.	0.00% 0/33 • 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.
Gastrointestinal disorders Abdominal pain	8.8% 3/34 • Number of events 3 • 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.	6.1% 2/33 • Number of events 2 • 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.
Renal and urinary disorders Urinary tract infection	2.9% 1/34 • Number of events 1 • 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.	6.1% 2/33 • Number of events 3 • 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.
Vascular disorders Sycope	5.9% 2/34 • Number of events 3 • 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.	3.0% 1/33 • Number of events 1 • 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.
Renal and urinary disorders Urinary incontinence	5.9% 2/34 • Number of events 2 • 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.	6.1% 2/33 • Number of events 2 • 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.