Could a palm extract help fight a rare genetic brain disease?
NCT ID NCT04658823
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a supplement called HOV-12020 (made from palm tocotrienols) in 50 adults aged 45-75 with CADASIL, a rare genetic disease that damages small blood vessels in the brain, leading to strokes and memory loss. The goal was to see if the supplement could reduce worsening of symptoms like stroke, disability, or cognitive decline over 24 months. Participants were randomly assigned to receive either the supplement or a placebo, and neither they nor their doctors knew which they received.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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50 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Oct 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
45 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female 2. Participants aged 45 to 75 years inclusive, at the time of signing of informed consent 3. Confirmed Diagnosis of CADASIL, defined by either: * A Typical mutation in the NOTCH3 gene responsible for an odd number of cystein residue OR * A positive skin biopsy showing typical granular osmiophilic material (GOM) in the vascular wall of small vessels with electron microscopy 4. Presence of at least one prevalent lacune on the MRI identified on 3DT1 or FLAIR images. 5. Presence of Confluent white matter hyperintensities (WMH) on T2-weighted or FLAIR MR images (Fazekas grade 2-3). 6. MMSE score ≥15 7. mRS at 0 - 3 8. A woman of child bearing potential (WOCBP) is eligible to participate if she is not pregnant, not breastfeeding, and agrees to follow contraceptive guidance (as described in Appendix 5) provided by the study clinician during the treatment period and for 28 days after the last dose of the study treatment. 9. Capable of giving signed informed consent and have a patient representative willing to co-sign informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: 1. Clinical stroke with persisting neurological deficit within 6 months prior to Screening. 2. Any other neurodegenerative disorder, such as Parkinson's disease, Alzheimer's disease, or Huntington's disease. 3. Current significant hematological, cardiac, pulmonary, metabolic, neurologic or psychiatric disorders, uncontrolled seizures, untreated hypertension, disorders increasing risk of bleeding (Hemophilia), or any other significant active medical condition which in the Investigator's opinion would impact participation in this study. 4. History of myocardial infarction within 3 months prior to Screening, or current active angina pectoris, or symptomatic heart failure. 5. History of cancer, within the past 5 years. Patients with basal cell carcinoma, squamous cell carcinoma, and Stage 1 prostate cancer can be included in the study. 6. An episode of major depression within the last 6 months prior to Screening (clinically stable minor depression is not exclusionary). 7. History of attempted suicide within 6 months prior to Screening or a positive response to items 4 or 5 of Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening and Baseline. 8. History of drug or alcohol abuse or dependence. 9. Contra-indications to MRI: presence of a pacemaker, severe claustrophobia, cochlear implants, ferromagnetic devices or clips, intracranial vascular clips, insulin pumps, metallic implants. 10. Pregnancy or breastfeeding women. 11. History of human immunodeficiency virus (HIV), hepatitis B or C. 12. History of allergy or severe intolerance to Vitamin E (tocopherols / tocotrienols). 13. Presence at Screening of alanine aminotransferase (ALT), aspartate aminotransferase (AST), amylase, or lipase 2x above the upper limit of normal (ULN) of laboratory reference range, total bilirubin 1.5x ULN, any other clinically significant laboratory abnormality. 14. Presence at Screening of Creatinine clearance \<60 (estimated by Cockcroft-Gault equation). 15. Cognitive enhancers such as donepezil, are allowed only if stable dosage within 3 months prior to Screening. 16. Use of tocotrienol supplementation within 3 months prior to Screening or any current use of Vitamin E other than study drug (all other vitamin supplements are allowed, if stable dosage within 3 months prior to screening). 17. Participation in a clinical trial with investigational product (IP) within 30 days prior to Screening. Patients participating in observational studies with no IP, will be allowed to participate in this study 18. Indication for anti-coagulant therapy 19. Patients with known sensitivity to polyoxyl castor oil or risk of allergy to soybean and peanuts.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Lariboisière APHP
Paris, 75010, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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