Neuroprotection of Memantine and Rosuvastatin

NCT07504198 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 36264MS461/12/23
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Memantine is used to slow the neurotoxicity of Alzheimer disease. Rosuvastatin used as a lipid-lowering agent . Increased bioavailability of endothelial-derived nitric oxide improves endothelium function , increases cerebral blood flow which may all contribute to the neuroprotective effects of rosuvastatin . The goal of this clinical trial is to prevent oxaliplatin induced peripheral neuropathy in patients with colorectal cancer.The aim of this current study is to assess the neuroprotective effect of memantine and rosuvastatin against oxaliplatin induced peripheral neuropathy.

Conditions

Peripheral Nerve Disease

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the percentage of patients with sensory neuropathy grade ≥ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events for grading of neuropathy from 1 to 5 based on severity.

  at base line and every two oxaliplatin cycle (each cycle is 14 days )

Secondary Outcomes (1)

• the changes in serum levels of the Serum neurofilament light chain as a biomarker of neuronal damage, Serum malondialdhyde as a marker of oxidative stress and Serum tumor necrosis factor alpha as a biomarker of inflammation

  at base line and after the completion of chemotherapy cycle(6 months)

Study Arms (2)

Standard group

PLACEBO COMPARATOR

Patients will receive modified FOLFOX-6 regimen or XELOX regimen The chemotherapy cycles will be received every 14 days for modified FOLFOX-6 regimen or every 21 days for XELOX regimen for 6 months and will be as follows :modified FOLFOX regimen , oxaliplatin 85 mg/m2 intravenous infusion in 500 mL 5% dextrose solution(on days 1 and 15) and leucovorin 400 mg/m2 intravenous infusion in 250 mL 5% dextrose solution both were given over 2 hours at the same time in separate bags using a Y-line access , followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 5 minutes, followed by 5-fluorouracil 2400 mg/m2 intravenous infusion in 500 mL 5% dextrose solution as a 46-hour infusion. XELOX regimen , oxaliplatin 130 mg/m2 intravenous infusion in 500 mL 5% dextrose over 2 hours and capecitabine 850 mg/m2 or 1000 mg/m2 per dose twice daily (total dose 1700 or 2000 per day )from evening of day 1 to morning of day15 plus starch placebo orally

Drug: Starch Placebo

Intervention group

ACTIVE COMPARATOR

patients with colorectal cancer will receive modified FOLFOX-6 regimen or XELOX regimen throughout the chemotherapy cycles plus memantine oral tablet 5 mg PO once daily initially; increased by increments of 5 mg/day each week; maintenance target dosage 20 mg/day and rosuvastatin tablet 20 mg orally daily.

Drug: Memantine; Drug: Rosuvastatin 20 Mg Oral Tablet

Interventions

Starch Placebo DRUG

starch placebo oral tablet will be given to patients plus the modified FOLFOX chemotherapy regimen or XELOX chemotherapy regimen

Standard group

Memantine DRUG

memantine 5 mg PO once daily initially; increased by increments of 5 mg/day each week; maintenance target dosage 20 mg/day

Intervention group

Rosuvastatin 20 Mg Oral Tablet DRUG

rosuvastatin 20 mg orally daily.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years old for both gender .
• Adequate baseline hematologic values (absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl).
• Patients with adequate renal function (serum creatinine \< 1.5 mg/dl or creatinine clearance ˃ 45 mL/min).
• Patients with adequate liver function (serum bilirubin \< 1.5 mg/dl).
• Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score.
• Patients who will be scheduled to receive modified FOLFOX-6 or XELOX regimen.
• Patients with histologically confirmed diagnosis of stage III or stage IV colorectal cancer.

You may not qualify if:

• Children \< 18 years old.
• Prior exposure to neurotoxic chemotherapy (oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH).
• Patients with diabetes and other conditions that predispose to neuropathy as hypothyroidism, autoimmune diseases, hepatitis C.
• History of known allergy to oxaliplatin or other platinum agents.
• Patients with other inflammatory or stressful conditions.
• Concomitant use of multivitamins (vitamins E, C, A), tricyclic antidepressants, other neuro-protective medications (gabapentin, lamotrigine, carbamazepine and phenytoin).
• Patients on amantadine , acetazolamide, dextromethorphan, aluminum hydroxide magnesium hydroxide and febuxostat .
• Concurrent active cancer originating from a primary site other than colon or rectum.
• Pregnant and breastfeeding women.
• Sever renal insufficiency (creatinine clearance \< 25 ml/ minute) .

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta

Tanta, Egypt

Location

Related Publications (3)

• Ma G, Liu C, Hashim J, et al. Memantine mitigates oligodendrocyte damage after repetitive mild traumatic brain injury. Neuroscience, 2019;421:152-161.

  BACKGROUND

• Wei G, Gu Z, Gu J, Yu J,et al. Platinum accumulation in oxaliplatin-induced peripheral neuropathy. J Peripher Nerv Syst., 2021;26(1):35-42.

  BACKGROUND

• Zisiadis GA, Alevyzaki A, Nicola E, et al. Memantine increases the dendritic complexity of hippocampal young neurons in the juvenile brain after cranial irradiation. Front Oncol., 2023;13:1202200.

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Memantine; Rosuvastatin Calcium; Tablets

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Eman Ayman Elsayed Abdallah a Abdallah, Pharm D

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Ayman Elsayed Abdallah a Abdallah, Pharm D

CONTACT

022+01285941144; aymanemy155@gmail.com

Eman Ibrahim Abd Elkhader El berry i Lecturer of Clinical Pharmacy, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: patients with colorectal cancer will receive the standard chemotherapy regimen therapy plus memantine 5 mg PO once daily initially; increased by increments of 5 mg/day each week; maintenance target dosage 20 mg/day and rosuvastatin 20 mg orally daily.

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 31, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)