Resveratrol and Huntington Disease

Not Applicable

Completed

• Conditions: Huntington Disease
• Interventions: Dietary Supplement: Resveratrol; Other: Placebo

• Registration Number: NCT02336633
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The purpose of this study is to evaluate the therapeutic potential of Resveratrol on the caudate volume in HD patients, using volumetric MRI.

Detailed Description

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 Timeline

• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-13
• Study Start: 2015-07
• Status Verified: 2019-08
• Primary Completion: 2019-10
• Study Completion: 2020-01
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Resveratrol	Resveratrol (80mg/j = 4 capsules/day)
2	Placebo	Placebo (4 capsules/day)

Primary Outcome Measures

Name	Time	Method
rate of caudate atrophy	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.

Secondary Outcome Measures

Name	Time	Method
UHDRS (Unified Huntington Disease Rating Scale)	1 year
TFC (Total Functional Capacity)	1 year
ratio of inorganic phosphate/phosphocreatine	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

Trial Locations

Locations (1)

Institut du Cerveau et de la Moelle, Hôpital de la Pitié Salpêtrière; 🇫🇷 Paris, France