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Portland, Oregon 97239

  • Alzheimer's Disease

Purpose:

The purpose of this study is to examine the safety and effectiveness of two anti-oxidant treatment regimens in patients with mild to moderate Alzheimer's disease. The anti-oxidant treatments include vitamin E + C + alpha-lipoic acid, and Coenzyme Q (CoQ).


Study summary:

Oxidative damage has been shown to be a factor in Alzheimer's disease (AD), and some studies have suggested that supplemental anti-oxidants can decrease the risk of AD or slow its progression. There are many candidate antioxidants, including combinations, which could be neuroprotective in established AD or could have efficacy in the prevention of AD. However, testing each of the possibilities in standard clinical trials is prohibitively expensive. This study will examine antioxidant supplements or vitamins which target specific cellular compartments, and look for evidence of biologically relevant effects in AD by measurement of biomarkers in CSF. Two general cellular compartments where antioxidant supplements may act are the cytosol and mitochondria. The study will examine a combination of antioxidants that act primarily at cytosolic sites (vitamin E + C + α-lipoic acid) and a single mitochondrial antioxidant, coenzyme Q10. This multicenter trial will recruit 75 participants who will be randomized into three groups: 1. 25 participants will be given a combination of vitamin E 800 IU, vitamin C 200 mg, and alpha-lipoic acid 600 mg formulated into three capsules, one capsule given three times per day with meals, plus two placebo wafers three times per day with meals; 2. 25 participants will be given CoQ 400 mg, compounded as a wafer, two wafers three times per day with meals, plus one placebo capsule three times per day with meals; 3. 25 participants will be given both the placebo wafers, two wafers three times per day with meals, plus one placebo capsule three times per day with meals. The treatment period will last four months. The effects of the two anti-oxidant treatments will be evaluated by measuring biomarkers in blood and cerebrospinal fluid (CSF) at the beginning and end of the 4-month period.


Criteria:

Inclusion Criteria: - Men or women aged 60-85, inclusive - Diagnosis of probable Alzheimer's disease - English-speaking; Spanish-speaking if individual site allows - Study partner or caregiver to assure compliance - Mini-Mental State Examination score at screening visit greater than 14 - Female participants either surgically sterile or postmenopausal for over 1 year - Stable medical condition for 3 months prior to screening, with no significant abnormal liver, kidney, or blood studies - Stable medications for 4 weeks prior to screening - Able to take oral medications - Modified Hachinski Ischemic Index less than or equal to 4 - CT or MRI since onset of memory impairment demonstrating the absence of a clinically significant focal lesion - Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam, and clinical tests Exclusion Criteria: - Significant neurologic disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis, or seizure disorder - Major depression in the past 12 months, major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse - History of invasive cancer within the past two years (excluding non-melanoma skin cancer) - Contra-indications to lumbar puncture - Use of any investigational agents within 30 days prior to screening - Major surgery within 8 weeks prior to the Baseline Visit - Uncontrolled cardiac conditions or severe unstable medical illnesses - Antiretroviral therapy for human immunodeficiency virus (HIV) - Conditions that will contribute to oxidative stress: current cigarette or cigar smokers (within past month), diabetics on insulin or poorly controlled on oral hypoglycemics - Residence in skilled nursing facility - Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol Note: Exceptions to these criteria may be considered on a case-by-case basis, at the discretion of the Project Director. Excluded Medications: - Experimental drugs - Coumadin - Insulin - Immunosuppressive agents: prednisone and other corticosteroids (taken orally or by injection), methotrexate, cyclophosphamide, cyclosporin, tacrolimus, etc. - HIV protease inhibitors - Neuroleptics and lithium - Anti-cancer agents (exception: stable doses of hormonal therapy, e.g. Lupron, estrogen, are permitted)


Study is Available At:


Original ID:

IA0067


NCT ID:

NCT00117403


Secondary ID:


Study Acronym:


Brief Title:

Anti-Oxidant Treatment of Alzheimer's Disease


Official Title:

Evaluation of the Safety, Tolerability and Impact on Biomarkers of Anti-Oxidant Treatment of Mild to Moderate Alzheimer's Disease


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Aging (NIA)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Douglas Galasko, MD
Principal Investigator
University of California, San Diego

Study Dates

Start Date:January 2006
Completion Date:September 2007
Completion Type:Actual
Primary Completion Date:September 2007
Primary Completion Type:Actual
Verification Date:April 2008
Last Changed Date:April 1, 2009
First Received Date:June 30, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage
Time Frame:baseline and 4 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:change in plasma and CSF concentrations of a-beta42 and a-beta40
Time Frame:baseline and 4 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Vitamin E, Vitamin C, and Alpha-lipoic Acid
Description:vitamin E 800 IU, vitamin C 200 mg, and alpha-lipoic acid 600 mg formulated into three capsules, one capsule given three times per day with meals
Arm Name:1
Intervention Type:Drug
Name:Coenzyme Q
Description:400 mg, compounded as a wafer, two wafers three times per day with meals
Arm Name:2
Intervention Type:Drug
Name:Placebo capsules
Description:one placebo capsule three times per day with meals
Arm Name:2
Intervention Type:Drug
Name:Placebo wafers
Description:two placebo wafers three times per day with meals
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:vitamin E 800 IU, vitamin C 200 mg, and alpha-lipoic acid 600 mg formulated into three capsules, one capsule given three times per day with meals, plus two placebo wafers three times per day with meals
Study Arm Type:Experimental
Arm Name:2
Description:CoQ 400 mg, compounded as a wafer, two wafers three times per day with meals, plus one placebo capsule three times per day with meals
Study Arm Type:Placebo Comparator
Arm Name:3
Description:two placebo wafers three times per day with meals, plus one placebo capsule three times per day with meals

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Aging (NIA)
Agency Class:Other
Agency Type:Collaborator
Agency Name:Alzheimer's Disease Cooperative Study (ADCS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Sano M, Ernesto C, Thomas RG, Klauber MR, Schafer K, Grundman M, Woodbury P, Growdon J, Cotman CW, Pfeiffer E, Schneider LS, Thal LJ. A controlled trial of selegiline, alpha-tocopherol, or both as treatment for Alzheimer's disease. The Alzheimer's Disease Cooperative Study. N Engl J Med. 1997 Apr 24;336(17):1216-22.
PMID:9110909
Reference Type:Reference
Citation:Behl C. Alzheimer's disease and oxidative stress: implications for novel therapeutic approaches. Prog Neurobiol. 1999 Feb;57(3):301-23. Review.
PMID:10096843
Reference Type:Reference
Citation:Zandi PP, Anthony JC, Khachaturian AS, Stone SV, Gustafson D, Tschanz JT, Norton MC, Welsh-Bohmer KA, Breitner JC; Cache County Study Group. Reduced risk of Alzheimer disease in users of antioxidant vitamin supplements: the Cache County Study. Arch Neurol. 2004 Jan;61(1):82-8.
PMID:14732624

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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