Alzheimer's DiseasePhase 1NCT00117403
Anti-Oxidant Treatment of Alzheimer's Disease
A Phase 1 study testing Vitamin E, Vitamin C, and Alpha-lipoic Acid and Coenzyme Q in people with Alzheimer's Disease, run by National Institute on Aging (NIA) at 13 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Vitamin E, Vitamin C, and Alpha-lipoic Acid and Coenzyme Q
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 13 sitesUnited States
- Study dates
- Jan 2006to Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Case Western Reserve University
Cleveland, Ohio, 44120
University of California- Irvine
Irvine, California, 92697
University of California, San Diego
La Jolla, California, 92037
University of Kentucky
Lexington, Kentucky, 40536
University of California, Los Angeles
Los Angeles, California, 90095
Wien Center, Mount Sinai Medical Center
Miami Beach, Florida, 33140
Medical University of South Carolina
North Charleston, South Carolina, 29406
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Medicine and Dentistry of New Jersey
Piscataway, New Jersey, 08855
Oregon Health Sciences University
Portland, Oregon, 97239
University of Washington
Seattle, Washington, 98108
Neurological Care of CNY
Syracuse, New York, 13210
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: Evaluation of the Safety, Tolerability and Impact on Biomarkers of Anti-Oxidant Treatment of Mild to Moderate Alzheimer's Disease
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).
Read the detailed description
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:
- 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;
- 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;
- 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Vitamin E, Vitamin C, and Alpha-lipoic Acid, Coenzyme Q, Placebo capsules, Placebo wafers
- Keywords
- dementia, anti-oxidant, biomarkers, alpha-tocopherol, CoQ
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E, Vitamin C, and Alpha-lipoic AcidDrug
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
Coenzyme QDrug
400 mg, compounded as a wafer, two wafers three times per day with meals
Placebo capsulesDrug
one placebo capsule three times per day with meals
Placebo wafersDrug
two placebo wafers three times per day with meals
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Placebo capsules; Drug: Placebo wafers |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage
Measured: baseline and 4 months
Secondary outcomes (1)
change in plasma and CSF concentrations of a-beta42 and a-beta40
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2005 (estimated)
- Study startJan 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Alzheimer's Disease Cooperative Study (ADCS)
- Investigators
- Douglas Galasko, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117403
- Sponsor's protocol ID
- IA0067
- Status last verified
- Apr 2008
- First submitted
- 30 Jun 2005
- Last updated
- 3 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9110909Behl 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.
PubMed 10096843Zandi 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.
PubMed 14732624Galasko 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.
PubMed 22431837
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Tolerability and Impact on Biomarkers of Anti-Oxidant Treatment of Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00117403
- Acronym / sponsor ID
- IA0067
- Conditions
- Alzheimer's Disease
- Keywords
- dementia, anti-oxidant, biomarkers, alpha-tocopherol, CoQ
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- Alzheimer's Disease Cooperative Study (ADCS)
- Study start
- Jan 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 6 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- 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;
- 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;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vitamin E, Vitamin C, and Alpha-lipoic Acid, Drug: Placebo wafersvitamin 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 | Experimental | Drug: Coenzyme Q, Drug: Placebo capsulesCoQ 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 | Placebo comparator | Drug: Placebo capsules, Drug: Placebo waferstwo placebo wafers three times per day with meals, plus one placebo capsule three times per day with meals |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin E, Vitamin C, and Alpha-lipoic Acidvitamin 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 | Drug | 1 |
| Coenzyme Q400 mg, compounded as a wafer, two wafers three times per day with meals | Drug | 2 |
| Placebo capsulesone placebo capsule three times per day with meals | Drug | 2, 3 |
| Placebo waferstwo placebo wafers three times per day with meals | Drug | 1, 3 |
Primary outcome
effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage
Time frame: baseline and 4 months
1 secondary outcome
change in plasma and CSF concentrations of a-beta42 and a-beta40
Time frame: baseline and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2009.
- Background: PubMed 9110909Sano 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.
- Background: PubMed 10096843Behl 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.
- Background: PubMed 14732624Zandi 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.
- Derived from this study: PubMed 22431837Galasko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Galasko, MD principal investigator
University of California, San Diego
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin E, Vitamin C, and Alpha-lipoic Acid and Coenzyme Q in people with Alzheimer's Disease, run by National Institute on Aging (NIA) at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (time frame: baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00117403, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2009.