PMID- 20837824
OWN - NLM
STAT- MEDLINE
DCOM- 20110214
LR  - 20211020
IS  - 1538-3687 (Electronic)
IS  - 0003-9942 (Linking)
VI  - 68
IP  - 1
DP  - 2011 Jan
TI  - A randomized pilot clinical trial of the safety of pioglitazone in treatment of 
      patients with Alzheimer disease.
PG  - 45-50
LID - 10.1001/archneurol.2010.229 [doi]
AB  - OBJECTIVES: To evaluate the safety of the peroxisome proliferator-activated 
      receptor gamma agonist pioglitazone in nondiabetic patients with Alzheimer 
      disease (AD) and to explore treatment effect sizes on clinical outcomes. DESIGN: 
      Double-blind, placebo-controlled randomized controlled trial of 18-month 
      duration. SETTING: Two academic medical center outpatient clinics. PATIENTS: 
      Nondiabetic patients meeting research criteria for probable AD were enrolled. 
      Twenty-five of 29 subjects completed the study; no withdrawals were attributable 
      to adverse effects. INTERVENTION: Subjects received pioglitazone (Actos), 
      titrated to 45 mg daily, or matching placebo, and 200 IU of vitamin E daily. 
      Patients maintained treatment with cholinesterase inhibitors and could begin 
      memantine therapy when it became available during the study. MAIN OUTCOME 
      MEASURES: The primary outcome was frequency of reported adverse effects (AEs). 
      Secondary outcomes were measures of cognition, activities of daily living, 
      neuropsychiatric symptoms, and global function. RESULTS: Peripheral edema was the 
      principal AE occurring more frequently in subjects taking pioglitazone than 
      placebo (28.6% vs 0%). This is consistent with the known AE profile of 
      pioglitazone. No group differences in laboratory measures were identified. No 
      significant treatment effect was observed on exploratory analysis of clinical 
      efficacy. CONCLUSIONS: Pioglitazone was generally well tolerated in this pilot 
      study. There were no serious or unanticipated adverse events or clinical 
      laboratory changes attributable to pioglitazone over a long-term exposure in 
      nondiabetic patients with AD. The tolerability of pioglitazone in this population 
      and peroxisome proliferator-activated receptor gamma effects in laboratory models 
      of AD support further study of this drug class in earlier disease stages. TRIAL 
      REGISTRATION: clinicaltrials.gov Identifier: NCT00982202.
FAU - Geldmacher, David S
AU  - Geldmacher DS
AD  - Department of Neurology, University of Virginia Health System, Charlottesville, 
      USA. dsg8n@virginia.edu
FAU - Fritsch, Thomas
AU  - Fritsch T
FAU - McClendon, McKee J
AU  - McClendon MJ
FAU - Landreth, Gary
AU  - Landreth G
LA  - eng
SI  - ClinicalTrials.gov/NCT00982202
GR  - R01 AG030482/AG/NIA NIH HHS/United States
GR  - R01AG18905/AG/NIA NIH HHS/United States
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
DEP - 20100913
PL  - United States
TA  - Arch Neurol
JT  - Archives of neurology
JID - 0372436
RN  - 0 (Blood Glucose)
RN  - 0 (Thiazolidinediones)
RN  - X4OV71U42S (Pioglitazone)
SB  - IM
CIN - Arch Neurol. 2011 Apr;68(4):542; author reply 542-3. PMID: 21482939
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/blood/*drug therapy/*psychology
MH  - Blood Glucose/drug effects/metabolism
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuropsychological Tests
MH  - Pain/chemically induced
MH  - Pilot Projects
MH  - Pioglitazone
MH  - Thiazolidinediones/*adverse effects/*therapeutic use
MH  - Treatment Outcome
EDAT- 2010/09/15 06:00
MHDA- 2011/02/15 06:00
CRDT- 2010/09/15 06:00
PHST- 2010/09/15 06:00 [entrez]
PHST- 2010/09/15 06:00 [pubmed]
PHST- 2011/02/15 06:00 [medline]
AID - archneurol.2010.229 [pii]
AID - 10.1001/archneurol.2010.229 [doi]
PST - ppublish
SO  - Arch Neurol. 2011 Jan;68(1):45-50. doi: 10.1001/archneurol.2010.229. Epub 2010 
      Sep 13.