Cognitive ImpairmentPhase 2/3NCT03342443
Effect of Memantine on Radiotherapy-related Cognitive Impairment
A Phase 2/3 study testing Memantine in people with Cognitive Impairment, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Purpose: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the therapeutic effects of thalidomide in radiotherapy-related cognitive impairment. Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2017to Dec 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have received radiation therapy due to head and neck cancer.
- Prior irradiation is ≥1.5 yearsand≤ 6 years.
- Age>/= 35 years but age</=60.
- Estimated life expectancy must be greater than 12 months.
- Cognitive impairment exists for more than 4 weeks, withMMSE≤26, or MoCA≤25.
- Routine laboratory studies with bilirubin </=1.0 * upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT)< 1.0 * ULN, creatinine<1.0 * ULN, white-cell count >/= 4,000 per cubic millimeter; neutrophils count >/=1500 per cubic millimeter, platelets >/= 100,000 per cubic millimeter; Hb>/=110 gram per millilitres. PT, APTT, INR in a normal range.
- Constant caregivers who well understand and have willingness to sign a written informed consent document.
Who cannot join
- evidence of tumor metastasis, recurrence, or invasion;
- evidence of very high intracranial pressure that suggests brain hernia and need surgery;
- previous treatment with memantine or other medications for cognitive impairment;
- history of mental disordersor cognitive impairment before radiotherapy;
- history of stroke, or high risk of vascular dementia;
- family history ofalzheimer's disease, pick's disease, etc.;
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- history of severe head trauma;
- clinically significant active disease, e.g. New York Heart Association Grade II or greater congestive heart failure, serious and inadequately controlled cardiac arrhythmia, significant vascular disease, severe infection;
- history of allergy to relevant drugs;
- pregnancy, lactation, or fertility program in the following 12 months;
- participation in other experimental studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Yamei Tang, Ph.D, 86-208-133-2620, yameitang@hotmail.com
Yi Li, Ph.D, 86-208-133-2620, eleam2002@163.com
About this study
Purpose: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the therapeutic effects of thalidomide in radiotherapy-related cognitive impairment.
Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang.
Primary outcome measure: cognitive improvement, which is determined by the difference value of ADAS-cog score before and after the treatment of memantine.
Read the detailed description
Application of radiotherapy to patients with head and neck cancer isa mainstay treatment in contemporaryoncology practice. However, patients who received radiation are vulnerable to development of cognitive impairment.There is no acknowledged and effective standard treatment for radiotherapy-related cognitive impairment. We supposed that memantine, as the N-methyl-D-aspartate receptor antagonist, would relieve radiotherapy-related cognitive impairment after head and neck cancer, and would improve the life quality for these patients and their families.
Primary objectives: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of memantineon cognition in radiotherapy-related cognitive impairment.
Secondary objectives:
To evaluate the effect of memantine on sleep disorder, mood disorder, activities of daily living, and safety in patients with radiotherapy-related cognitive impairment.
OUTLINE: This is randomized, double-blind, placebo-controlled clinical trial. Patients will be enrolled and administrated with memantine or placebo. Memantine will be supplied as 10 mg per pill to be taken by mouth. Placebo will be supplied as substitute of 10 mg memantine per pill to be taken by mouth.
Patients will be screened, consented, enrolled and have a washout period for 6 weeks. Then these patients will be randomized to two arms.
Arm І: Patients receive memantine with a dosage of 5 microgram at 8 am daily for one week (Week 1), then 5 microgram at 8 am and5 microgram at 5 pm for one week (Week 2), then 10 microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
Arm ІI: Patients receive placebo with a dosage of one half pill at 8 am daily for one week (Week 1), then one half pill at 8 am and one half pill at 5 pm for one week (Week 2), then one pill at 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
- Conditions
- Cognitive Impairment
- Being tested
- Memantine, Placebo
- Keywords
- memantine, radiotherapy-related cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Arm I
Patients receive memantine with a dosage of 5 microgram at 8 am daily for one week (Week 1), then 5 microgram at 8 am and 5 microgram at 5 pm for one week (Week 2), then 10 microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
PlaceboDrug
Also called Arm II
Patients receive placebo with a dosage of one halfpill at 8 am daily for one week (Week 1), then one halfpillat 8 am andone half pill at 5 pm for one week (Week 2), then one pillat 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
| Study group | Role | What they receive |
|---|---|---|
| memantine | Experimental | Patients receive memantine with a dosage of 5 microgram at 8 am daily for one week (Week 1), then 5 microgram at 8 am and 5 microgram at 5 pm for one week (Week 2), then 10 microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration. Receives: Drug: Memantine |
| placebo | Placebo comparator | Patients receive placebo with a dosage of one halfpill at 8 am daily for one week (Week 1), then one halfpillat 8 am andone half pill at 5 pm for one week (Week 2), then one pillat 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive improvement
Cognitive improvement is determined by the difference value of ADAS-cog score before and after the treatment of memantine.
Measured: Baseline to Week 24
Secondary outcomes (5)
improvement of global condition
Improvement of global condition is determined by the difference values of CIBIC-plus before and after the treatment of memantine.
Measured: Baseline to Week 24
improvement of activities of daily living
Improvement of activities of daily living is determined by the difference values of ADL before and after the treatment of memantine.
Measured: Baseline to Week 24
improvement of activities of daily living
Improvement of activities of daily living is determined by the difference values of Clinical Dementia Rating before and after the treatment of memantine.
Measured: Baseline to Week 24
improvement of mental statement
Improvement of mental statement is determined by the difference values of MMSE before and after the treatment of memantine.
Measured: Baseline to Week 24
improvement of psychological statement, including sleep disorder, mood disorder, etc.
Improvement of psychological statement, including sleep disorder, mood disorder, etc. is determined by the difference values of Neuropsychiatric Inventory (NPI) before and after the treatment of memantine.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start6 Dec 2017
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342443
- Sponsor's protocol ID
- 20161208
- Status last verified
- Apr 2019
- First submitted
- 5 May 2017
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Memantine on Radiotherapy-related Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03342443
- Acronym / sponsor ID
- 20161208
- Conditions
- Cognitive Impairment
- Keywords
- memantine, radiotherapy-related cognitive impairment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Nov 2017 (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.
Purpose: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the therapeutic effects of thalidomide in radiotherapy-related cognitive impairment.
Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang.
Primary outcome measure: cognitive improvement, which is determined by the difference value of ADAS-cog score before and after the treatment of memantine.
Detailed description
Application of radiotherapy to patients with head and neck cancer isa mainstay treatment in contemporaryoncology practice. However, patients who received radiation are vulnerable to development of cognitive impairment.There is no acknowledged and effective standard treatment for radiotherapy-related cognitive impairment. We supposed that memantine, as the N-methyl-D-aspartate receptor antagonist, would relieve radiotherapy-related cognitive impairment after head and neck cancer, and would improve the life quality for these patients and their families.
Primary objectives: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of memantineon cognition in radiotherapy-related cognitive impairment.
Secondary objectives:
To evaluate the effect of memantine on sleep disorder, mood disorder, activities of daily living, and safety in patients with radiotherapy-related cognitive impairment.
OUTLINE: This is randomized, double-blind, placebo-controlled clinical trial. Patients will be enrolled and administrated with memantine or placebo. Memantine will be supplied as 10 mg per pill to be taken by mouth. Placebo will be supplied as substitute of 10 mg memantine per pill to be taken by mouth.
Patients will be screened, consented, enrolled and have a washout period for 6 weeks. Then these patients will be randomized to two arms.
Arm І: Patients receive memantine with a dosage of 5 microgram at 8 am daily for one week (Week 1), then 5 microgram at 8 am and5 microgram at 5 pm for one week (Week 2), then 10 microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
Arm ІI: Patients receive placebo with a dosage of one half pill at 8 am daily for one week (Week 1), then one half pill at 8 am and one half pill at 5 pm for one week (Week 2), then one pill at 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| memantine | Experimental | Drug: MemantinePatients receive memantine with a dosage of 5 microgram at 8 am daily for one week (Week 1), then 5 microgram at 8 am and 5 microgram at 5 pm for one week (Week 2), then 10 microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration. |
| placebo | Placebo comparator | Drug: PlaceboPatients receive placebo with a dosage of one halfpill at 8 am daily for one week (Week 1), then one halfpillat 8 am andone half pill at 5 pm for one week (Week 2), then one pillat 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients must have received radiation therapy due to head and neck cancer.
- Prior irradiation is ≥1.5 yearsand≤ 6 years.
- Age>/= 35 years but age</=60.
- Estimated life expectancy must be greater than 12 months.
- Cognitive impairment exists for more than 4 weeks, withMMSE≤26, or MoCA≤25.
Key exclusion criteria (11 listed)
- evidence of tumor metastasis, recurrence, or invasion;
- evidence of very high intracranial pressure that suggests brain hernia and need surgery;
- previous treatment with memantine or other medications for cognitive impairment;
- history of mental disordersor cognitive impairment before radiotherapy;
- history of stroke, or high risk of vascular dementia;
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 |
|---|---|---|
| MemantineAlso: Arm IPatients receive memantine with a dosage of 5 microgram at 8 am daily for one week (Week 1), then 5 microgram at 8 am and 5 microgram at 5 pm for one week (Week 2), then 10 microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration. | Drug | memantine |
| PlaceboAlso: Arm IIPatients receive placebo with a dosage of one halfpill at 8 am daily for one week (Week 1), then one halfpillat 8 am andone half pill at 5 pm for one week (Week 2), then one pillat 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration. | Drug | placebo |
Primary outcome
cognitive improvement
Time frame: Baseline to Week 24
Cognitive improvement is determined by the difference value of ADAS-cog score before and after the treatment of memantine.
5 secondary outcomes
improvement of global condition
Time frame: Baseline to Week 24
improvement of activities of daily living
Time frame: Baseline to Week 24
improvement of activities of daily living
Time frame: Baseline to Week 24
improvement of mental statement
Time frame: Baseline to Week 24
improvement of psychological statement, including sleep disorder, mood disorder, etc.
Time frame: Baseline to Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 in people with Cognitive Impairment, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 11 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: status not confirmed, as of the sponsor's last update on 12 Apr 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yamei Tang, Ph.D (86-208-133-2620, yameitang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive improvement (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2019.