Clinical trial · Interventional
Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer
Memantine for Prevention of Cognitive Decline During Adjuvant or Neoadjuvant Chemotherapy in Patients With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose: To conduct a one-arm phase II trial to: (1) compare changes in pre- to post-chemotherapy cognitive function in a cohort of patients with breast cancer receiving memantine to historical controls; (2) examine how depression, anxiety, fatigue, baseline Intelligence Quotient (IQ), and cognitive effort relate to objective and self-reported cognitive function; and (3) estimate the feasibility of conducting a clinical trial of memantine for attenuating cognitive decline in patients with breast cancer during chemotherapy. Participants: Adult patients with stage I-III breast cancer scheduled for adjuvant or neoadjuvant chemotherapy. Procedures (methods): Cognitive assessments will be performed within one week of initiating and four weeks after completion of chemotherapy. Patients will receive memantine 10 mg twice daily between the pre- and post-chemotherapy study assessments. Cognitive function will be assessed objectively using a computerized cognitive test (Delayed Matching to Sample (DMS) test) and a standard neuropsychological battery. To assess subjective cognitive function, the Patient Reported Outcome Measurement Information System (PROMIS) Cognitive Function measure will be used. Depression, anxiety, fatigue, menopausal status, and sleep will be assessed as covariates.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemo-brain | — | UNRESOLVED | — |
| Cognitive Decline | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Memantine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Memantine
- description
- Subjects receive memantin
- interventionNames
- Drug: Memantine
Primary outcomes (1)
- measure
- Change in Visual Working Memory - Delayed Matching to Sample Test
- timeFrame
- From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy
- description
- The Delayed Matching to Sample Test (DMS) is a computerized cognitive assessment of visual working memory. The DMS will be administered using Cambridge Neuropsychological Test Automated Battery (CANTAB) eclipse software (Cambridge Cognition, Cambridge, UK). The participant is shown an image with four patterns and asked to match patterns simultaneously or after delay. The investigators will use the percent correct (0 to 100, higher is better) at the 12-second delay on the DMS test for the primary analysis.
Secondary outcomes (16)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide informed consent * At least 18 years of age * Able to speak English * Diagnosed with breast cancer, Stages I-III * Scheduled for adjuvant or neoadjuvant chemotherapy Exclusion Criteria: * A history of adverse reaction to memantine * Another cancer diagnosis with an estimated survival of less than five years * Previous chemotherapy exposure * Severe cognitive impairment, defined as Blessed Orientation Memory Concentration Test (BOMC) ≥ 11. * Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment, or breastfeeding * Current alcohol or drug abuse
References
Publications (1)
- DERIVEDNakamura ZM, Deal AM, Park EM, Stanton KE, Lopez YE, Quillen LJ, O'Hare Kelly E, Heiling HM, Nyrop KA, Ray EM, Dees EC, Reeder-Hayes KE, Jolly TA, Carey LA, Abdou Y, Olajide OA, Rauch JK, Joseph R, Copeland A, McNamara MA, Ahles TA, Muss HB. A phase II single-arm trial of memantine for prevention of cognitive decline during chemotherapy in patients with early breast cancer: Feasibility, tolerability, acceptability, and preliminary effects. Cancer Med. 2023 Apr;12(7):8172-8183. doi: 10.1002/cam4.5619. Epub 2023 Jan 16. PMID 36645168