Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2015-07-31
2020-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Resveratrol (80mg/j = 4 capsules/day)
Resveratrol
2 capsules of 20mg in the morning and in the evening (4 capsules in total/day = 80mg/day) every day during 1 year
2
Placebo (4 capsules/day)
Placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* Signature of the informed consent
* Covered by social security
* UHDRS score between 5 and 40 (both included)
* Ability to undergo MRI scanning
Exclusion Criteria
* Tetrabenazine treatment
* Neuroleptic treatments other than olanzapine at small doses (≤10 mg) and Abilify® (≤15mg)
* VKA treatment (Previscan®, Sintron®, Coumadine®)
* NACO treatment (Pradaxa®, Xarelto®, Eliquis®)
* Additional psychiatric or neurological conditions
* Severe head injury
* Participation in another therapeutic trial (3 months exclusion period)
* Pregnancy and breastfeeding
* Inability to understand information about the protocol
* Persons deprived of their liberty by judicial or administrative decision
* Adult subject under legal protection or unable to consent.
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Fanny Mochel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Institut du Cerveau et de la Moelle, Hôpital de la Pitié Salpêtrière
Paris, , France
Countries
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Other Identifiers
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P130918
Identifier Type: -
Identifier Source: org_study_id
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