Table 3.
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.