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. 2022 Jan 28;11(2):212. doi: 10.3390/biology11020212

Table 3.

Completed clinical trials conducted for antioxidants relevant to AD (“Completed” status here means the study has ended, and participants are no longer being examined or treated (that is, the last participant’s last visit has occurred).

Sl. No. NCT Number Conditions Interventions Outcome Measures Phases
1 NCT00117403
(https://clinicaltrials.gov/show/NCT00117403, accessed on 20 December 2021)
AD Drugs: Vitamin E, Vitamin C, and Alpha-lipoic Acid
Drug: Coenzyme Q
Drug: Placebo capsules
Drug: Placebo wafers
Effect on CSF biomarkers related to oxidative damage change in plasma and CSF concentrations of Aβ42 and Aβ40 Phase 1
2 NCT00090402
(https://clinicaltrials.gov/show/NCT00090402, accessed on 20 December 2021)
AD
Oxidative Stress
Dementia
Hyperlipidemia
Inflammation
Dietary Supplement: Fish Oil
Dietary Supplement: Lipoic Acid
Other: Fish Oil Placebo
Other: Lipoic Acid Placebo
F2-isoprostane Level: Urine F2-Isoprostanes
Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months
Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months
Phase 1
Phase 2
3 NCT00678431
(https://clinicaltrials.gov/show/NCT00678431, accessed on 20 December 2021)
AD Dietary Supplement: Resveratrol with Glucose and Malate
Dietary Supplement: Placebo
Alzheimer’s Disease Assessment Scale (ADAScog)
CGIC
Phase 3
4 NCT00000173
(https://clinicaltrials.gov/show/NCT00000173, accessed on 20 December 2021)
AD Drug: Donepezil
Drug: Vitamin E
Phase 3
5 NCT00951834
(https://clinicaltrials.gov/show/NCT00951834, accessed on 20 December 2021)
AD Drug: Epigallocatechin-Gallate
Drug: Placebo
ADAS-COG (Score 0–70) (Baseline to treatment)
Safety and tolerability of the verum
MMSE (Score 0–30) after 18 months compared to baseline
Time to hospitalization and Time to death related to AD
Brain atrophy assessed by brain MRI
Baseline-ADAS-COG and Baseline-MMSE as covariates
CIBIC+ and WHO-QOL-Bref
Trail Making Test and MVGT
Phase 2
Phase 3
6 NCT01707719
(https://clinicaltrials.gov/show/NCT01707719, accessed on 20 December 2021)
AD
Oxidative-Stress
Adrenocortical-hyperfunction
Malondialdehyde assay
Relationship between urinary excretion of cortisol and levels of malondialdehyde
7 NCT00628017
(https://clinicaltrials.gov/show/NCT00628017, accessed on 20 December 2021)
AD
Mild Cognitive Impairment
Dietary Supplement: omega-3 polyunsaturated fatty acids (EPA+DHA) The Clinician’s Interview-Based Impression of Change Scale (CIBIC-plus)
The cognitive portion of the Alzheimer’s Disease Assessment Scale (ADAS-cog)
Mini-Mental Status Examination (MMSE) score
17-item Hamilton Depression Scale (HDRS)
18-adverse events
Not Applicable
8 NCT00099710
(https://clinicaltrials.gov/show/NCT00099710, accessed on 20 December 2021)
AD Dietary Supplement: Curcumin C3 Complex Side effect checklist
Oxidative damage
Inflammation/gliosis
A-beta levels
Tau levels
Total plasma cholesterol, LDL and HDL; ApoE
Plasma curcumin and metabolites
Cognitive and behavioral measures
Phase 2
9 NCT00597376
(https://clinicaltrials.gov/show/NCT00597376, accessed on 20 December 2021)
Subjective Memory Loss in Older Persons Other: Cerefolin NAC (a medical food)
Other: Cerefolin NAC placebo
Six-month blood levels of Homocysteine, Glutathione, and the Ratio of Aβ42 to Aβ40 (as a Percent of Baseline Levels) After Daily Intake of Cerefolin NAC Plus a Multivitamin Versus a Multivitamin Only
Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only
Six Month Levels of Inflammation and Oxidative Stress Markers (as a Percent of Baseline Levels) After Daily Treatment with Cerefolin NAC and a Multivitamin or a Multivitamin Only
Not Applicable
10 NCT00940589
(https://clinicaltrials.gov/show/NCT00940589, accessed on 20 December 2021)
AD
Sleep Disorder
Drug: Circadin
Drug: Placebo
Change From Baseline to 24 Weeks in ADAS-cog
Change From Baseline to 24 Weeks in iADL
Change From Baseline to 24 Weeks in MMSE
Phase 2
11 NCT00000171
(https://clinicaltrials.gov/show/NCT00000171, accessed on 20 December 2021)
AD
Dyssomnias
Drug: Melatonin Phase 3
12 NCT01058941
(https://clinicaltrials.gov/show/NCT01058941, accessed on 20 December 2021)
AD Drug: Lipoic acid and fish oil concentrate
Drug: Placebo
Change From Baseline in Activities of Daily Living (ADL) at 18 Months
Change From Baseline in Alzheimer’s Disease Assessment Scale—Cognitive Subscale (ADAS-cog) at 18 Months
Phase 1
Phase 2
13 NCT01370954
(https://clinicaltrials.gov/show/NCT01370954, accessed on 20 December 2021)
Early Memory Loss
MCI
AD
VaD
Other: CerefolinNAC® To determine if CerefolinNAC® affects a subject’s quality of life as measured by the Quality of Life-Alzheimer’s Disease Scale (QOL-AD)
To determine overall patient satisfaction with CerefolinNAC® using a 9-point satisfaction scale
14 NCT01504854
(https://clinicaltrials.gov/show/NCT01504854, accessed on 20 December 2021)
AD Drug: Resveratrol
Drug: Placebo
Number of Adverse Events
Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI)
Change in Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Comparison of the Response to Treatment of Resveratrol Based on ApoE Genotype
Phase 2
15 NCT00040378
(https://clinicaltrials.gov/show/NCT00040378, accessed on 20 December 2021)
AD Drug: alphatocopherol
Drug: Selenium
Drug: Placebo replacement for vitamin E
Drug: Placebo replacement for Selenium
Incidence of dementia (including Alzheimer’s disease)
16 NCT00235716
(https://clinicaltrials.gov/show/NCT00235716, accessed on 20 December 2021)
AD Drug: dl-alpha-tocopherol
Drug: Memantine
Drug: Placebo
Alzheimer’s Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
Mini-Mental State Examination Change From Baseline
Alzheimer’s Disease Assessment Scale—Cognitive (ADAS-cog) Change From Baseline
Neuropsychiatric Inventory Change From Baseline
Caregiver Activity Survey Change From Baseline
Dependence Scale: Time to Event Analysis (Increase of One Dependence Level)
Phase 3
17 NCT01716637
(https://clinicaltrials.gov/show/NCT01716637, accessed on 20 December 2021)
AD Biological: Etanercept
Dietary Supplement: Curcum.Luteol.Theaflav.Lip.Acid, FishOil, Quercet., Resveratr.
The difference in effects of treatment for 6 weeks with etanercept + nutritional supplements versus nutritional supplements alone on the Mini-Mental Status Examination (MMSE) score;
The difference in the effects of treatment for six weeks with etanercept + nutritional supplements versus nutritional supplements alone on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog) score;
The difference in the effects of treatment for six weeks with etanercept + nutritional supplements versus nutritional supplements alone on the Montreal Cognitive Assessment (MoCA) score
Phase 1
18 NCT00692510
(https://clinicaltrials.gov/show/NCT00692510, accessed on 20 December 2021)
AD Drug: AZD3480
Drug: Placebo
Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)
PK variables
Safety variables (adverse events, blood pressure, pulse, safety lab)
Phase 1
19 NCT01594346
(https://clinicaltrials.gov/show/NCT01594346, accessed on 20 December 2021)
AD
DS
Drug: Alpha-Tocopherol
Drug: Sugar Pill
The Brief Praxis Test
The Fuld Object Memory Test
New Dot Test
Orientation Test
Vocabulary Test
Behavior and Function
Clinical Global Impression
Incident Dementia
Phase 3
20 NCT01780974
(https://clinicaltrials.gov/show/NCT01780974, accessed on 20 December 2021)
Treated Hypertension Drug: Lipoic Acid plus Omega-3 Fatty Acids
Drug: Placebo
Trails Making Test Part B (Executive Function)
White Matter Hyperintensity Volume (Brain MRI)
Phase 1
Phase 2
21 NCT01699711
(https://clinicaltrials.gov/show/NCT01699711, accessed on 20 December 2021)
DS Dietary Supplement: Epigallocatechin-3-gallate (EGCG) Change in Cognitive Evaluation and Amyloidosis Biomarker
Treatment compliance
Change in Biomarkers of lipid oxidation and DYRK1A activity biomarkers
COMT val158met genetic polymorphism (catechol methyl transferase) (Taqman)
Change in AST (SGOT-serum glutamic oxaloacetic transaminase-) and ALT (SGPT-Serum Glutamic Pyruvate Transaminase-) (Pentra Autoanalyzer, and ELISA Mercodia for LDLox)
Change in Body Composition by electrical impedance (TANITA-MC-180)
Changes in Neurophysiology
Phase 2

Aβ, amyloid-β; Acetylcholinesterase, AChE; AD, Alzheimer’s disease; APOE, apolipoprotein E; CSF, cerebrospinal fluid; DS, Down syndrome; MMSE, mini-mental state examination; VaD, vascular dementia; MCI, Mild Cognitive Impairment.