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. 2020 Aug 20;8(9):295. doi: 10.3390/biomedicines8090295

Table 3.

Clinical trials of scyllo-inositol and d-pinitol in Alzheimer’s disease-related patients. Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Alzheimer’s Disease Cooperative Study Clinician’s Global Impression of Change (ADCS-CCGIC), Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), Clinical Dementia Rating-Sum of Boxes (CDR-SB), Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A), Neuropsychological Test Battery (NTB), Treatment Emergent Adverse Events (TEAEs).

Inositol Title, NCT Number, and Date Dose Population Outcome Measures Published Results
Scyllo-inositol (ELND005)

  • ELND005 in Patients with Mild to Moderate Alzheimer’s Disease

  • Study Start: December 2007

  • Study Completion: May 2010

  • NCT00568776

 Placebo,
250 mg/kg;
1000 mg/kg;
2000 mg/kg at 78 weeks

  • Enrollment: 353

  • Age: 50 Years to 85 Years (Adult, Older Adult)

  • ADCS-ADL

  • ADAS-Cog

  • CDR-SB

  • NPI

  • NTB

 [201]

  • ELND005 Long-Term Follow-up Study in Subjects With Alzheimer’s Disease

  • Study Start: June 2009

  • Study Completion: June 2011

  • NCT00934050

 Placebo,
250 mg/kg;
post-Dec 2009, 2000 mg/kg; pre-Dec 2009, 48 weeks

  • Enrollment: 103

  • Age: Child, Adult, Older Adult

  • TEAEs

 Confidence agreement

  • Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer’s Disease

  • Study Start: November 2012

  • Study Completion: May 2015

  • NCT01735630

 Placebo, film coated tablets, twice a day for 12 weeks

  • Enrollment: 350

  • Age: 50 Years to 95 Years (Adult, Older Adult)

  • ADCS-ADL

  • ADCS-CGIC

  • MMSE

  • NPI-C A+A

 Confidence agreement

  • A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer’s Disease

  • Study Start: January 2013

  • Study Completion: August 2015

  • NCT01766336

 Continue at same dose as previous clinical trial for 36 weeks

  • Enrollment: 296

  • Age: 50 Years to 95 Years (Adult, Older Adult)

  • TEAEs

 Confidence agreement

  • A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia

  • Study Start: September 2013

  • Study Completion: June 2014

  • NCT01791725

 Placebo,
250 mg/kg once a day;
250 mg/kg twice a day,
4 weeks

  • Enrollment: 23

  • Age: 18 Years to 45 Years (Adult)

  • TEAEs

 [234]
d-pinitol (NIC5-15)

  • Development of NIC5-15 in The Treatment of Alzheimer’s Disease

  • Study Start: January 2007

  • Study Completion: March 2010

  • NCT00470418

 Placebo;
dose not specified,
7 weeks

  • Enrollment: 15

  • Age: Child, Adult, Older Adult

  • TEAEs

  • Clinical Measures of Cognition at Terminal Visit

 [242]

  • A Single Site, Randomized, Double-blind, Placebo Controlled Trial of NIC5-15 in Subjects With Alzheimer’s Disease

  • Study Start: April 2007

  • Study Completion: June 2014

  • NCT01928420

 Placebo;
dose not specified,
24 weeks

  • Enrollment: 30

  • Age: 40 Years to 95 Years (Adult, Older Adult)

  • ADCS-ADL

  • ADCS-CGIC

  • ADAS-Cog

  • MMSE

  • NPI

  • Changes in AD biomarkers, APO-E genotyping

 N/A