Anti-Oxidant Treatment of Alzheimer's Disease

NCT00117403 | Completed Phase 1 DMC

• 1 other identifier: IA0067
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 13

Brief Summary

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).

Conditions

Alzheimer's Disease

Keywords

dementia; anti-oxidant; biomarkers; alpha-tocopherol; CoQ

Outcome Measures

Primary Outcomes (1)

• effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage

  baseline and 4 months

Secondary Outcomes (1)

• change in plasma and CSF concentrations of a-beta42 and a-beta40

  baseline and 4 months

Study Arms (3)

1

EXPERIMENTAL

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

Drug: Vitamin E, Vitamin C, and Alpha-lipoic Acid; Drug: Placebo wafers

2

EXPERIMENTAL

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

Drug: Coenzyme Q; Drug: Placebo capsules

3

PLACEBO COMPARATOR

two placebo wafers three times per day with meals, plus one placebo capsule three times per day with meals

Drug: Placebo capsules; Drug: Placebo wafers

Interventions

Vitamin E, Vitamin C, and Alpha-lipoic Acid DRUG

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

1

Coenzyme Q DRUG

400 mg, compounded as a wafer, two wafers three times per day with meals

2

Placebo capsules DRUG

one placebo capsule three times per day with meals

2; 3

Placebo wafers DRUG

two placebo wafers three times per day with meals

1; 3

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): lead
• Alzheimer's Disease Cooperative Study (ADCS): collaborator

Study Sites (13)

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California- Irvine

Irvine, California, 92697, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Wien Center, Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Medicine and Dentistry of New Jersey

Piscataway, New Jersey, 08855, United States

Location

Neurological Care of CNY

Syracuse, New York, 13210, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44120, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

North Charleston, South Carolina, 29406, United States

Location

University of Washington

Seattle, Washington, 98108, United States

Location

Related Publications (4)

• 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. doi: 10.1056/NEJM199704243361704.

  PMID: 9110909 BACKGROUND

• Behl C. Alzheimer's disease and oxidative stress: implications for novel therapeutic approaches. Prog Neurobiol. 1999 Feb;57(3):301-23. doi: 10.1016/s0301-0082(98)00055-0.

  PMID: 10096843 BACKGROUND

• 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. doi: 10.1001/archneur.61.1.82.

  PMID: 14732624 BACKGROUND

• Galasko DR, Peskind E, Clark CM, Quinn JF, Ringman JM, Jicha GA, Cotman C, Cottrell B, Montine TJ, Thomas RG, Aisen P; Alzheimer's Disease Cooperative Study. Antioxidants for Alzheimer disease: a randomized clinical trial with cerebrospinal fluid biomarker measures. Arch Neurol. 2012 Jul;69(7):836-41. doi: 10.1001/archneurol.2012.85.

  PMID: 22431837 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Vitamin E; Ascorbic Acid; Thioctic Acid; Ubiquinone

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Benzoquinones; Quinones

Study Officials

• Douglas Galasko, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 6, 2005
• Study Start: January 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 3, 2009

Record last verified: 2008-04

Locations

US (13)