NCT05834231

Brief Summary

Memantine is a drug for the management of Alzheimer's Disease (AD) due to its promising neuroprotective properties. We hypothesize that Memantine possesses a beneficial role against chemotherapy-induced neuronal damages.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_1 cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 17, 2023

Last Update Submit

April 17, 2023

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria

    6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR
Drug: Memantine

Control

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MemantineDRUG

oral

Intervention
PlaceboDRUG

oral

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed diagnosis of stage III colorectal cancer performance status \< 2 according to Eastern Cooperative Oncology Group (ECOG) score adequate renal function (glomerular filtration rate ≥ 90)

You may not qualify if:

  • preexisting neuropathic or brain disorders, a previous use of chemotherapeutic agents including oxaliplatin use of drugs reported to have neuroprotective role

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Memantine

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Clinical Pharmacy

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 28, 2023

Study Start

August 1, 2023

Primary Completion

March 1, 2024

Study Completion

October 1, 2024

Last Updated

April 28, 2023

Record last verified: 2023-04