Resveratrol and Huntington Disease (REVHD)
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|ClinicalTrials.gov Identifier: NCT02336633|
Recruitment Status : Recruiting
First Posted : January 13, 2015
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Huntington Disease||Dietary Supplement: Resveratrol Other: Placebo||Phase 3|
Thanks to neuroimaging biomarkers already validated in HD and the newly identified metabolic brain biomarkers using 31P-MRS, we can test for a reduction in neurodegeneration among HD patients resulting from an improvement in brain energy profiles with resveratrol.
We plan to randomize 102 early affected HD patients (with a maximum of 120 included patients) in France (5≤UHDRS≤40) in a randomized, double-blind, controlled study. Patients will receive either resveratrol at 80 mg (n=51), or placebo (n=51) for 12 months. Clinical benefit will be respectively evaluated by UHDRS and neuropsychiatric questionnaires; biological tolerance will be evaluated by routine biochemical blood tests and plasma measurements of resveratrol, these three factors will be tested every three months.
The primary end-point will be the measure of the rate of caudate atrophy - the most sensitive biomarker identified to date in HD - after one year of treatment with resveratrol in early affected HD patients using volumetric MRI as we described.
Secondary end-points include:
The clinical and biological tolerance of resveratrol in HD patients will be evaluated by (i) neuropsychiatric questionnaires: Starkstein apathy scale, Hospital Anxiety and Depression Scale (HADS), Systems Behaviour Inventory (FrSBe) and SF36, (ii) a cognitive test; Symbol Digit Modalities Test (SDMT) and (iii) routine biochemical tests The clinical benefit of resveratrol will be evaluated by a decrease in the progression of the UHDRS over a year of treatment The benefit of resveratrol on brain energy metabolism will be evaluated by the restoration of an increased ratio of inorganic phosphate/phosphocreatine - reflecting normal brain activation - during visual stimulation, using 31P-MRS as we described The progression of caudate atrophy over a year will be correlated with the changes in brain energy profile as well as changes in the progression of the UHDRS.
The compliance of treatment and peak in plasmatic concentration through plasma measurements of resveratrol.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Metabolic Intervention Using Resveratrol in Patients With Huntington Disease|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
U.S. FDA Resources
Resveratrol (80mg/j = 4 capsules/day)
Dietary Supplement: Resveratrol
2 capsules of 20mg in the morning and in the evening (4 capsules in total/day = 80mg/day) every day during 1 year
Placebo Comparator: 2
Placebo (4 capsules/day)
- rate of caudate atrophy [ Time Frame: 1 year ]Measurement of the rate of caudate atrophy before and after one year of treatment with resveratrol in early affected HD patients using volumetric MRI.
- UHDRS (Unified Huntington Disease Rating Scale) [ Time Frame: 1 year ]
- TFC (Total Functional Capacity) [ Time Frame: 1 year ]
- ratio of inorganic phosphate/phosphocreatine [ Time Frame: 1 year ]The benefit of resveratrol on brain energy metabolism will be evaluated by the restoration of an increased ratio of inorganic phosphate/phosphocreatine - reflecting normal brain activation - during visual stimulation, using 31P-MRS will be assessed before and after 1 year of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336633
|Contact: Magali Barbier||+33 (0)1 firstname.lastname@example.org|
|Institut du Cerveau et de la Moelle, Hôpital de la Pitié Salpêtrière||Recruiting|
|Paris, France, 75013|
|Contact: Tiffany Monnier, M Scs|
|Principal Investigator:||Fanny Mochel, MD, PhD||Assistance Publique - Hôpitaux de Paris|