Peripheral Nerve DiseasePhase 2/3NCT07504198
Neuroprotection of Memantine and Rosuvastatin
A Phase 2/3 study testing Memantine and Rosuvastatin 20 Mg Oral Tablet in people with Peripheral Nerve Disease, run by Tanta University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Disease
- What is being tested?
- Memantine and Rosuvastatin 20 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2026to May 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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) .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eman Ibrahim Abd Elkhader El berry i Lecturer of Clinical Pharmacy, MD contact
About this study
Official title: Neuroprotective Effect of Memantine and Rosuvastatin Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
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.
Read the detailed description
Memantine treatment ameliorated oxaliplatin-elevated intracellular production of reactive oxygen species and lipid product malondialdehyde expression. Memantine alleviated impairment of the mitochondrial membrane potential and ATP production by oxaliplatin Rosuvastatin decreases axonal injury and cortical thickness. Rosuvastatin attenuated the chronic constriction injury induced neuropathic pain and inflammation .Thus, antinociceptive effects of rosuvastatin might be channeled through inhibition of inflammatory biomarkers and antioxidant properties .
- Conditions
- Peripheral Nerve Disease
- Being tested
- Starch Placebo, Memantine, Rosuvastatin 20 Mg Oral Tablet
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starch PlaceboDrug
starch placebo oral tablet will be given to patients plus the modified FOLFOX chemotherapy regimen or XELOX chemotherapy regimen
MemantineDrug
memantine 5 mg PO once daily initially; increased by increments of 5 mg/day each week; maintenance target dosage 20 mg/day
Rosuvastatin 20 Mg Oral TabletDrug
rosuvastatin 20 mg orally daily.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Memantine; Drug: Rosuvastatin 20 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: at base line and after the completion of chemotherapy cycle(6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nerve DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ayman Elsayed Abdallah, Tanta University
- Investigators
- Eman Ayman Elsayed Abdallah a Abdallah, Pharm D, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504198
- Sponsor's protocol ID
- 36264MS461/12/23
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma G, Liu C, Hashim J, Conley G, Morriss N, Meehan WP, Qiu J, Mannix R. Memantine Mitigates Oligodendrocyte Damage after Repetitive Mild Traumatic Brain Injury. Neuroscience. 2019 Nov 21;421:152-161. doi: 10.1016/j.neuroscience.2019.10.016. Epub 2019 Nov 1.
PubMed 31682950Wei G, Gu Z, Gu J, Yu J, Huang X, Qin F, Li L, Ding R, Huo J. Platinum accumulation in oxaliplatin-induced peripheral neuropathy. J Peripher Nerv Syst. 2021 Mar;26(1):35-42. doi: 10.1111/jns.12432. Epub 2021 Jan 27.
PubMed 33462873Zisiadis GA, Alevyzaki A, Nicola E, Rodrigues CFD, Blomgren K, Osman AM. Memantine increases the dendritic complexity of hippocampal young neurons in the juvenile brain after cranial irradiation. Front Oncol. 2023 Oct 4;13:1202200. doi: 10.3389/fonc.2023.1202200. eCollection 2023.
PubMed 37860190
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Effect of Memantine and Rosuvastatin Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07504198
- Acronym / sponsor ID
- 36264MS461/12/23
- Conditions
- Peripheral Nerve Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Memantine treatment ameliorated oxaliplatin-elevated intracellular production of reactive oxygen species and lipid product malondialdehyde expression. Memantine alleviated impairment of the mitochondrial membrane potential and ATP production by oxaliplatin Rosuvastatin decreases axonal injury and cortical thickness. Rosuvastatin attenuated the chronic constriction injury induced neuropathic pain and inflammation .Thus, antinociceptive effects of rosuvastatin might be channeled through inhibition of inflammatory biomarkers and antioxidant properties .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard group | Placebo comparator | Drug: Starch PlaceboPatients 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 |
| Intervention group | Active comparator | Drug: Memantine, Drug: Rosuvastatin 20 Mg Oral Tabletpatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starch Placebostarch placebo oral tablet will be given to patients plus the modified FOLFOX chemotherapy regimen or XELOX chemotherapy regimen | Drug | Standard group |
| Memantinememantine 5 mg PO once daily initially; increased by increments of 5 mg/day each week; maintenance target dosage 20 mg/day | Drug | Intervention group |
| Rosuvastatin 20 Mg Oral Tabletrosuvastatin 20 mg orally daily. | Drug | Intervention group |
Primary outcome
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.
Time frame: at base line and every two oxaliplatin cycle (each cycle is 14 days )
1 secondary outcome
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
Time frame: at base line and after the completion of chemotherapy cycle(6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 31682950Ma G, Liu C, Hashim J, Conley G, Morriss N, Meehan WP, Qiu J, Mannix R. Memantine Mitigates Oligodendrocyte Damage after Repetitive Mild Traumatic Brain Injury. Neuroscience. 2019 Nov 21;421:152-161. doi: 10.1016/j.neuroscience.2019.10.016. Epub 2019 Nov 1.
- Background: PubMed 33462873Wei G, Gu Z, Gu J, Yu J, Huang X, Qin F, Li L, Ding R, Huo J. Platinum accumulation in oxaliplatin-induced peripheral neuropathy. J Peripher Nerv Syst. 2021 Mar;26(1):35-42. doi: 10.1111/jns.12432. Epub 2021 Jan 27.
- Background: PubMed 37860190Zisiadis GA, Alevyzaki A, Nicola E, Rodrigues CFD, Blomgren K, Osman AM. Memantine increases the dendritic complexity of hippocampal young neurons in the juvenile brain after cranial irradiation. Front Oncol. 2023 Oct 4;13:1202200. doi: 10.3389/fonc.2023.1202200. eCollection 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eman Ibrahim Abd Elkhader El berry i Lecturer of Clinical Pharmacy, MD contact
Eman Ayman Elsayed Abdallah a Abdallah, Pharm D principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Memantine and Rosuvastatin 20 Mg Oral Tablet in people with Peripheral Nerve Disease, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman Ayman Elsayed Abdallah a Abdallah, Pharm D (022+01285941144, aymanemy155@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: at base line and every two oxaliplatin cycle (each cycle is 14 days )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07504198, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.