Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Resveratrol for Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier:
NCT01504854
First received: December 23, 2011
Last updated: May 6, 2016
Last verified: April 2016
Results First Received: January 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Resveratrol
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A multicenter, double-blind, placebo-controlled trial was conducted June 2012–March 2014 with participants recruited from 26 US academic clinics affiliated with the Alzheimer’s Disease Cooperative Study (ADCS).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
119 subjects were recruited rather than 120.

Reporting Groups
  Description
Resveratrol

Subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.

Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily).

Placebo

Subjects will receive a matching placebo to be taken with or without food.

Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily.


Participant Flow:   Overall Study
    Resveratrol   Placebo
STARTED   64   55 
COMPLETED   56   48 
NOT COMPLETED   8   7 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Resveratrol

60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.

Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily).

Placebo

60 subjects will receive a matching placebo to be taken with or without food.

Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily.

Total Total of all reporting groups

Baseline Measures
   Resveratrol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 64   55   119 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.8  (7.7)   73  (8.2)   71.4  (7.95) 
Gender 
[Units: Participants]
     
Female   40   28   68 
Male   24   27   51 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Adverse Events   [ Time Frame: Baseline, Weeks 6, 13, 19, 26, 32, 39, 45, and 52 ]

2.  Primary:   Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI)   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)   [ Time Frame: Week 52 ]

4.  Secondary:   Comparison of the Response to Treatment of Resveratrol Based on ApoE Genotype   [ Time Frame: Week 52 ]

5.  Post-Hoc:   Change From Baseline in Cerebrospinal Fluid Amyloid β40 Concentration at 52 Weeks   [ Time Frame: Baseline and Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This phase 2 study has limitations. A larger study is required to determine whether resveratrol may be beneficial. More potent and bioavailable SIRT1 activators are also in development.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Rafii, MD, PhD
Organization: Alzheimer's Disease Cooperative Study
phone: 858-846-1300
e-mail: mrafii@ucsd.edu


Publications:

Responsible Party: Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier: NCT01504854     History of Changes
Other Study ID Numbers: ADC-037-RES
Study First Received: December 23, 2011
Results First Received: January 28, 2016
Last Updated: May 6, 2016
Health Authority: United States: Food and Drug Administration