Skip to content
2000
Volume 31, Issue 17
  • ISSN: 1381-6128
  • E-ISSN: 1873-4286
file format text download EPUB
file format pdf download PDF
side by side viewer icon HTML

Abstract

Objective

This study aimed to evaluate the effectiveness and safety of Altibrain in combination with standard Autism Spectrum Disorder (ASD) treatment compared to standard ASD treatment alone in individuals diagnosed with ASD.

Methods

A randomized, open-label trial was conducted involving 120 participants aged 3 to 17 years, randomly assigned to either the Standard ASD Treatment group or the Altibrain + Standard ASD Treatment group. Sixty patients were randomly allocated to each Standard ASD Treatment group or the Altibrain + Standard ASD Treatment group. Participant allocation was done by computer-generated randomization. Participants had confirmed ASD diagnoses based on DSM-V or ICD-11 criteria and demonstrated moderate to severe core ASD symptoms. Informed consent was obtained from caregivers. A total number of 120 subjects were included, consisting of 71 male and 49 female patients. Participants received either standard ASD treatment alone or Altibrain in addition to standard ASD treatment orally once daily for 24 weeks. A total of 7 study visits/24 weeks to analyze the intervention efficacy of the Standard ASD Treatment group or the Altibrain + Standard ASD Treatment group. Primary outcomes included changes in core ASD symptoms measured by the Autism Diagnostic Observation Schedule (ADOS) and safety assessments. Secondary outcomes included alterations in social communication skills, reduction in repetitive behaviors, overall functional improvements, safety and tolerability of Altibrain.

Results

Altibrain significantly improved qualitative deficits in social interaction and repetitive behaviors compared to standard ASD treatment alone ( < 0.0001). The Altibrain + Standard ASD Treatment group demonstrated significant improvements in social functioning, social awareness, cognition, communication, and motivation compared to the Standard ASD Treatment group ( < 0.0001). Additionally, Altibrain showed superior efficacy in reducing hyperactivity/noncompliance, inappropriate speech, irritability, lethargy/ social withdrawal, stereotypic behavior, and aberrant behavior compared to standard treatment alone ( < 0.0001). Additionally, Altibrain exhibited a favorable safety profile as per the 4-week post-treatment safety follow-up.

Conclusion

Overall, Altibrain holds promise as a valuable therapeutic option for individuals with ASD and their families. Limitations of the study include neuroimaging and biomarkers analysis and larger cohort studies.

© 2025 The Author(s). Published by Bentham Science Publishers.
This is an open access article published under CC BY 4.0 https://creativecommons.org/licenses/by/4.0/legalcode
Loading

Article metrics loading...

/content/journals/cpd/10.2174/0113816128335544241210144541
2025-05-01
2025-10-09

  • From This Site

    /content/journals/cpd/10.2174/0113816128335544241210144541
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
Loading full text...

Full text loading...

/deliver/fulltext/cpd/31/17/CPD-31-17-05.html?itemId=/content/journals/cpd/10.2174/0113816128335544241210144541&mimeType=html&fmt=ahah

References

  1. HirotaT. KingB.H. Autism spectrum disorder.JAMA2023329215716810.1001/jama.2022.23661 36625807
     [Google Scholar]
  2. ZhaoM. HavrillaJ. PengJ. Development of a phenotype ontology for autism spectrum disorder by natural language processing on electronic health records.J. Neurodev. Disord.20221413210.1186/s11689‑022‑09442‑0 35606697
     [Google Scholar]
  3. AsifM. MartinianoH.F.M.C. MarquesA.R. Identification of biological mechanisms underlying a multidimensional ASD phenotype using machine learning.Transl. Psychiatry20201014310.1038/s41398‑020‑0721‑1 32066720
     [Google Scholar]
  4. BeversdorfD.Q. Phenotyping, etiological factors, and biomarkers: Toward precision medicine in autism spectrum disorders.J. Dev. Behav. Pediatr.201637865967310.1097/DBP.0000000000000351 27676697
     [Google Scholar]
  5. EapenV. ČrnčecR. WalterA. Exploring links between genotypes, phenotypes, and clinical predictors of response to early intensive behavioral intervention in autism spectrum disorder.Front. Hum. Neurosci.2013756710.3389/fnhum.2013.00567 24062668
     [Google Scholar]
  6. ChangJ. GilmanS.R. ChiangA.H. SandersS.J. VitkupD. Genotype to phenotype relationships in autism spectrum disorders.Nat. Neurosci.201518219119810.1038/nn.3907 25531569
     [Google Scholar]
  7. HodgesH. FealkoC. SoaresN. Autism spectrum disorder: Definition, epidemiology, causes, and clinical evaluation.Transl. Pediatr.20209S1S55S6510.21037/tp.2019.09.09 32206584
     [Google Scholar]
  8. NapoliE. WongS. Hertz-PicciottoI. GiuliviC. Deficits in bioenergetics and impaired immune response in granulocytes from children with autism.Pediatrics20141335e1405e141010.1542/peds.2013‑1545 24753527
     [Google Scholar]
  9. NadeemA AhmadSF AL-Ayadhi LY, et al Differential regulation of Nrf2 is linked to elevated inflammation and nitrative stress in monocytes of children with autism.Psychoneuroendocrinology202011310455410.1016/j.psyneuen.2019.104554 31884317
     [Google Scholar]
  10. VargasD.L. NascimbeneC. KrishnanC. ZimmermanA.W. PardoC.A. Neuroglial activation and neuroinflammation in the brain of patients with autism.Ann. Neurol.2005571678110.1002/ana.20315 15546155
     [Google Scholar]
  11. GiuliviC. ZhangY.F. Omanska-KlusekA. Mitochondrial dysfunction in autism.JAMA2010304212389239610.1001/jama.2010.1706 21119085
     [Google Scholar]
  12. CurranL.K. NewschafferC.J. LeeL.C. CrawfordS.O. JohnstonM.V. ZimmermanA.W. Behaviors associated with fever in children with autism spectrum disorders.Pediatrics20071206e1386e139210.1542/peds.2007‑0360 18055656
     [Google Scholar]
  13. SharmaA. MehanS. Targeting PI3K-AKT/mTOR signaling in the prevention of autism.Neurochem. Int.202114710506710.1016/j.neuint.2021.105067 33992742
     [Google Scholar]
  14. LiuH. TalalayP. FaheyJ.W. Biomarker-guided strategy for treatment of autism spectrum disorder (ASD).CNS Neurol. Disord. Drug Targets201615560261310.2174/1871527315666160413120414 27071792
     [Google Scholar]
  15. JiangC.C. LinL.S. LongS. Signalling pathways in autism spectrum disorder: Mechanisms and therapeutic implications.Signal Transduct. Target. Ther.20227122910.1038/s41392‑022‑01081‑0 35817793
     [Google Scholar]
  16. ZimmermanA.W. SinghK. ConnorsS.L. Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder.Mol. Autism20211213810.1186/s13229‑021‑00447‑5 34034808
     [Google Scholar]
  17. MomtazmaneshS. Amirimoghaddam-YazdiZ. MoghaddamH.S. MohammadiM.R. AkhondzadehS. Sulforaphane as an adjunctive treatment for irritability in children with autism spectrum disorder: A randomized, double‐blind, placebo‐controlled clinical trial.Psychiatry Clin. Neurosci.202074739840510.1111/pcn.13016 32347624
     [Google Scholar]
  18. Hartley-McAndrewM. MertzJ. HoffmanM. CrawfordD. Rates of autism spectrum disorder diagnosis under the DSM-5 criteria compared to DSM-IV-TR criteria in a hospital-based clinic.Pediatr. Neurol.201657343810.1016/j.pediatrneurol.2016.01.012 26869267
     [Google Scholar]
  19. HuertaM. BishopS.L. DuncanA. HusV. LordC. Application of DSM-5 criteria for autism spectrum disorder to three samples of children with DSM-IV diagnoses of pervasive developmental disorders.Am. J. Psychiatry2012169101056106410.1176/appi.ajp.2012.12020276 23032385
     [Google Scholar]
  20. MaennerM.J. RiceC.E. ArnesonC.L. Potential impact of DSM-5 criteria on autism spectrum disorder prevalence estimates.JAMA Psychiatry201471329230010.1001/jamapsychiatry.2013.3893 24452504
     [Google Scholar]
  21. BellC.C. DSM-IV: Diagnostic and statistical manual of mental disorders.JAMA19942721082882910.1001/jama.1994.03520100096046
     [Google Scholar]
  22. BruniT.P. Test review: Social responsiveness scale–second edition (SRS-2).J. Psychoed. Assess.201432436536910.1177/0734282913517525
     [Google Scholar]
  23. MoonS.J. HwangJ.S. ShinA.L. Accuracy of the childhood autism rating scale: A systematic review and meta‐analysis.Dev. Med. Child Neurol.20196191030103810.1111/dmcn.14246 30977125
     [Google Scholar]
  24. O’BoyleM. Adaptive Behavior Scales. In: Volkmar FR, Ed. Encyclopedia of autism spectrum disorders.New York, NYSpringer2013555810.1007/978‑1‑4419‑1698‑3_224
     [Google Scholar]
  25. BusnerJ. TargumS.D. The clinical global impressions scale: Applying a research tool in clinical practice.Psychiatry (Edgmont)2007472837 20526405
     [Google Scholar]
  26. YangJ. HeL. DaiS. Therapeutic efficacy of sulforaphane in autism spectrum disorders and its association with gut microbiota: Animal model and human longitudinal studies.Front. Nutr.202410129405710.3389/fnut.2023.1294057 38260076
     [Google Scholar]
  27. KazdobaT.M. LeachP.T. YangM. SilvermanJ.L. SolomonM. CrawleyJ.N. Translational mouse models of autism: Advancing toward pharmacological therapeutics.Curr. Top. Behav. Neurosci.20162815210.1007/7854_2015_5003
     [Google Scholar]
  28. SilvermanJ.L. ThurmA. EthridgeS.B. Reconsidering animal models used to study autism spectrum disorder: Current state and optimizing future.Genes Brain Behav.2022215e1280310.1111/gbb.12803
     [Google Scholar]
  29. Leslie Baxter. A study to evaluate behavioral intervention designed to increase functional independence during aging in autism spectrum disorder (ASD) 2023; Available from: https://www.who.int/news-room/fact-sheets/detail/autism-spectrum-disorders?gad_source=1&gclid=EAIaIQobChMIuZKIwPCwiQMVfRkGAB0StTcDEAAYASAAEgKv6fD_BwE
  30. HusV. BishopS. GothamK. HuertaM. LordC. Factors influencing scores on the social responsiveness scale.J. Child Psychol. Psychiatry201354221622410.1111/j.1469‑7610.2012.02589.x 22823182
     [Google Scholar]
  31. ChanW. SmithL.E. HongJ. GreenbergJ.S. MailickM.R. Validating the social responsiveness scale for adults with autism.Autism Res.201710101663167110.1002/aur.1813 28639377
     [Google Scholar]
  32. SlomskiA. Preemptive treatment reduced autism symptom severity.JAMA202132621212010.1001/jama.2021.21430 34874432
     [Google Scholar]
  33. WhitehouseA.J.O. VarcinK.J. PillarS. Effect of preemptive intervention on developmental outcomes among infants showing early signs of autism.JAMA Pediatr.202117511e21329810.1001/jamapediatrics.2021.3298 34542577
     [Google Scholar]
  34. HookerJ.L. DowD. MorganL. SchatschneiderC. WetherbyA.M. Psychometric analysis of the repetitive behavior scale‐revised using confirmatory factor analysis in children with autism.Autism Res.20191291399141010.1002/aur.2159 31246379
     [Google Scholar]
  35. LordC. BrughaT.S. CharmanT. Autism spectrum disorder.Nat. Rev. Dis. Primers202061510.1038/s41572‑019‑0138‑4 31949163
     [Google Scholar]
  36. ChalihaD. MamoJ.C. AlbrechtM. LamV. TakechiR. VaccarezzaM. A systematic review of the MDMA model to address social impairment in autism.Curr. Neuropharmacol.20211971101115410.2174/1570159X19666210101130258 33388021
     [Google Scholar]
  37. RobbA.S. AnderssonC. BellocchioE.E. Safety and tolerability of aripiprazole in the treatment of irritability associated with autistic disorder in pediatric subjects (6-17 years old): results from a pooled analysis of 2 studies.Prim. Care Companion CNS Disord.20111312727510.4088/PCC.10m01008gry 21731831
     [Google Scholar]
  38. AmanM.G. FindlingR.L. HardanA.Y. Safety and efficacy of memantine in children with autism: Randomized, placebo-controlled study and open-label extension.J. Child Adolesc. Psychopharmacol.201727540341210.1089/cap.2015.0146
     [Google Scholar]
  39. De FilippisM. WagnerK.D. Treatment of autism spectrum disorder in children and adolescents.Psychopharmacol. Bull.20164621841
     [Google Scholar]
  40. FryeR.E. VassallS. KaurG. LewisC. KarimM. RossignolD. Emerging biomarkers in autism spectrum disorder: A systematic review.Ann. Transl. Med.2019723792210.21037/atm.2019.11.53 32042808
     [Google Scholar]
  41. JensenA.R. LaneA.L. WernerB.A. McLeesS.E. FletcherT.S. FryeR.E. Modern biomarkers for autism spectrum disorder: Future directions.Mol. Diagn. Ther.202226548349510.1007/s40291‑022‑00600‑7 35759118
     [Google Scholar]
  42. BentS. LawtonB. WarrenT. Identification of urinary metabolites that correlate with clinical improvements in children with autism treated with sulforaphane from broccoli.Mol. Autism2018913510.1186/s13229‑018‑0218‑4 29854372
     [Google Scholar]
  43. WolffJ.J. JacobS. ElisonJ.T. The journey to autism: Insights from neuroimaging studies of infants and toddlers.Dev Psychopathol.201830247949510.1017/S0954579417000980 28631578
     [Google Scholar]
  44. MellemaC.J. NguyenK.P. TreacherA. MontilloA. Reproducible neuroimaging features for diagnosis of autism spectrum disorder with machine learning.Sci. Rep.2022121305710.1038/s41598‑022‑06459‑2 35197468
     [Google Scholar]
  45. ChannellM.M. The Social Responsiveness Scale (SRS-2) in school-age children with Down syndrome at low risk for autism spectrum disorder.Autism Dev. Lang. Impair.20205239694152096240610.1177/2396941520962406 34179506
     [Google Scholar]
  46. ShahrivarZ. Tehrani-DoostM. DavoodiE. The reliability of the social responsiveness scale-2 in an Iranian typically developing group of children.Iran. J. Psychiatry2020151414610.18502/ijps.v15i1.2438 32377213
     [Google Scholar]
  47. BognerJ.A. CorriganJ.D. BodeR.K. HeinemannA.W. Rating scale analysis of the agitated behavior scale.J. Head Trauma Rehabil.200015165666910.1097/00001199‑200002000‑00005 10745182
     [Google Scholar]
/content/journals/cpd/10.2174/0113816128335544241210144541
Loading
Efficacy and Safety of Altibrain® as an Adjunctive Therapy for Autism Spectrum Disorder: An Open Label Trial Targeting Core Symptoms
Curr. Pharm. Des. 31, 1388 (2025); https://doi.org/10.2174/0113816128335544241210144541
/content/journals/cpd/10.2174/0113816128335544241210144541
/content/journals/cpd/10.2174/0113816128335544241210144541
Loading

Data & Media loading...

Supplements

Supplementary material is available on the publisher’s website along with the published article.

file format download Download

  • Article Type:     Research Article
Keyword(s): Altibrain®; Autism spectrum disorder (ASD); repetitive behaviors; social communication; stereotypical behavior; sulforaphane

Most Cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test