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Antioxidants for Alzheimer disease: a randomized clinical trial with cerebrospinal fluid biomarker measures.
Arch Neurol 2012; 69(7):836-41AN

Abstract

OBJECTIVE

To evaluate whether antioxidant supplements presumed to target specific cellular compartments affected cerebrospinal fluid (CSF) biomarkers.

DESIGN

Double-blind, placebo-controlled clinical trial.

SETTING

Academic medical centers.

PARTICIPANTS

Subjects with mild to moderate Alzheimer disease.

INTERVENTION

Random assignment to treatment for 16 weeks with 800 IU/d of vitamin E (α-tocopherol) plus 500 mg/d of vitamin C plus 900 mg/d of α-lipoic acid (E/C/ALA); 400 mg of coenzyme Q 3 times/d; or placebo.

MAIN OUTCOME MEASURES

Changes from baseline to 16 weeks in CSF biomarkers related to Alzheimer disease and oxidative stress, cognition (Mini-Mental State Examination), and function (Alzheimer's Disease Cooperative Study Activities of Daily Living Scale).

RESULTS

Seventy-eight subjects were randomized; 66 provided serial CSF specimens adequate for biochemical analyses. Study drugs were well tolerated, but accelerated decline in Mini-Mental State Examination scores occurred in the E/C/ALA group, a potential safety concern. Changes in CSF Aβ42, tau, and P-tau(181) levels did not differ between the 3 groups. Cerebrospinal fluid F2-isoprostane levels, an oxidative stress biomarker, decreased on average by 19% from baseline to week 16 in the E/C/ALA group but were unchanged in the other groups.

CONCLUSIONS

Antioxidants did not influence CSF biomarkers related to amyloid or tau pathology. Lowering of CSF F2-isoprostane levels in the E/C/ALA group suggests reduction of oxidative stress in the brain. However, this treatment raised the caution of faster cognitive decline, which would need careful assessment if longer-term clinical trials are conducted.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00117403.

Authors+Show Affiliations

Department of Neurosciences, University of California, San Diego, 92093, USA. dgalasko@ucsd.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

22431837

Citation

Galasko, Douglas R., et al. "Antioxidants for Alzheimer Disease: a Randomized Clinical Trial With Cerebrospinal Fluid Biomarker Measures." Archives of Neurology, vol. 69, no. 7, 2012, pp. 836-41.
Galasko DR, Peskind E, Clark CM, et al. Antioxidants for Alzheimer disease: a randomized clinical trial with cerebrospinal fluid biomarker measures. Arch Neurol. 2012;69(7):836-41.
Galasko, D. R., Peskind, E., Clark, C. M., Quinn, J. F., Ringman, J. M., Jicha, G. A., ... Aisen, P. (2012). Antioxidants for Alzheimer disease: a randomized clinical trial with cerebrospinal fluid biomarker measures. Archives of Neurology, 69(7), pp. 836-41.
Galasko DR, et al. Antioxidants for Alzheimer Disease: a Randomized Clinical Trial With Cerebrospinal Fluid Biomarker Measures. Arch Neurol. 2012;69(7):836-41. PubMed PMID: 22431837.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antioxidants for Alzheimer disease: a randomized clinical trial with cerebrospinal fluid biomarker measures. AU - Galasko,Douglas R, AU - Peskind,Elaine, AU - Clark,Christopher M, AU - Quinn,Joseph F, AU - Ringman,John M, AU - Jicha,Gregory A, AU - Cotman,Carl, AU - Cottrell,Barbara, AU - Montine,Thomas J, AU - Thomas,Ronald G, AU - Aisen,Paul, AU - ,, PY - 2012/3/21/entrez PY - 2012/3/21/pubmed PY - 2012/12/10/medline SP - 836 EP - 41 JF - Archives of neurology JO - Arch. Neurol. VL - 69 IS - 7 N2 - OBJECTIVE: To evaluate whether antioxidant supplements presumed to target specific cellular compartments affected cerebrospinal fluid (CSF) biomarkers. DESIGN: Double-blind, placebo-controlled clinical trial. SETTING: Academic medical centers. PARTICIPANTS: Subjects with mild to moderate Alzheimer disease. INTERVENTION: Random assignment to treatment for 16 weeks with 800 IU/d of vitamin E (α-tocopherol) plus 500 mg/d of vitamin C plus 900 mg/d of α-lipoic acid (E/C/ALA); 400 mg of coenzyme Q 3 times/d; or placebo. MAIN OUTCOME MEASURES: Changes from baseline to 16 weeks in CSF biomarkers related to Alzheimer disease and oxidative stress, cognition (Mini-Mental State Examination), and function (Alzheimer's Disease Cooperative Study Activities of Daily Living Scale). RESULTS: Seventy-eight subjects were randomized; 66 provided serial CSF specimens adequate for biochemical analyses. Study drugs were well tolerated, but accelerated decline in Mini-Mental State Examination scores occurred in the E/C/ALA group, a potential safety concern. Changes in CSF Aβ42, tau, and P-tau(181) levels did not differ between the 3 groups. Cerebrospinal fluid F2-isoprostane levels, an oxidative stress biomarker, decreased on average by 19% from baseline to week 16 in the E/C/ALA group but were unchanged in the other groups. CONCLUSIONS: Antioxidants did not influence CSF biomarkers related to amyloid or tau pathology. Lowering of CSF F2-isoprostane levels in the E/C/ALA group suggests reduction of oxidative stress in the brain. However, this treatment raised the caution of faster cognitive decline, which would need careful assessment if longer-term clinical trials are conducted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00117403. SN - 1538-3687 UR - https://www.unboundmedicine.com/medline/citation/22431837/Antioxidants_for_Alzheimer_disease:_a_randomized_clinical_trial_with_cerebrospinal_fluid_biomarker_measures_ L2 - https://jamanetwork.com/journals/jamaneurology/fullarticle/10.1001/archneurol.2012.85 DB - PRIME DP - Unbound Medicine ER -