ISRCTN79794378进行中（未招募）3 期
COmBining memantine And cholinesterase inhibitors in Lewy body dementia Treatment trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 372
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 21/12/2023:
- •1. Patients with a diagnosis or clinical features consistent with established consensus criteria for probable DLB or probable PDD
- •2. Aged =55 years
- •3. MMSE score =8. Evidence of mild, moderate, or moderate to severe cognitive impairment on similar global cognitive scales previously completed by their clinical care team (e.g., Addenbrooke’s Cognitive Examination, Mini-Addenbrooke’s Cognitive Examination, Montreal Cognitive Assessment) can be used to pre-screen the patient, prior to approach.
- •4. Receiving a stable dose of AChEI for =12 weeks prior to baseline, with no expected plans for dose adjustment during the trial period; dose adjustment will be allowed during the trial, if clinically indicated, following discussion with PI and, if required, the central trial team
- •5. If receiving any antiparkinsonian treatment, antidepressants, anxiolytics, antipsychotics, or other drugs with significant psychotropic effects then dose must be stable for a minimum of 4 weeks prior to enrolment with no expected plans for dose adjustment during the trial period. Dose adjustment will be allowed during the trial if clinically indicated and will be documented. If a change in medication with psychotropic effects is required, this decision can be made by the treating clinician (e.g., starting an antidepressant in clinic) without consultation with the CI. In some instances, the clinician may feel it is appropriate/relevant to discuss this with the PI prior to prescribing, for example, if the clinician feels that the medication change may have an impact on the trial and/or trial medication. Any changes should however be documented in the patient’s concomitant medications electronic Case Report Form (eCRF).
- •6. Patients who lack capacity will be required to have a personal/professional nominated representative who is able to give informed consent on the patient’s behalf
- •7. Females must be postmenopausal and not receiving IVF treatment or must have undergone permanent sterilisation. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •8. Patients with sufficient knowledge of the English language or support to understand the Patient Information Sheet and complete the trial assessments
- •Previous inclusion criteria:
- •1. Patients with a diagnosis or clinical features consistent with established consensus criteria for probable DLB or probable PDD.
- •2. Aged =50.
- •3. MMSE score = 8.*
- •4. Receiving a stable dose of AChEI for =12 weeks prior to baseline, with no expected plans for dose adjustment during the trial period; dose adjustment will be allowed during the trial, if clinically indicated, following discussion with PI and, if required, the central trial team.
- •5. If receiving any antiparkinsonian treatment, antidepressants, anxiolytics, antipsychotics, or other drugs with significant psychotropic effects then dose must be stable for a minimum of 4 weeks prior to enrolment with no expected plans for dose adjustment during the trial period. †
- •6. Patients who lack capacity will be required to have a personal/professional nominated representative who is able to give informed consent on the patient’s behalf.
- •7. 7.Females must be postmenopausal and not receiving IVF treatment or must have undergone permanent sterilisation††
- •8. Patients with sufficient knowledge of the Englis
排除标准
- •1. Atypical clinical features or course suggestive of an alternative dementia diagnosis.
- •2. Any clinically relevant concomitant disease that will affect ability to participate in the trial including, but not limited to, chronic renal disease stage 5, history of acute or chronic pancreatitis, epilepsy or former history of convulsions, patients with recent myocardial infarction (within last 6 months), uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension.
- •3. Patients with severe hepatic impairment based on known history and/or significant abnormalities identified in blood liver function tests (for example, levels in liver function tests that are 2-3 times higher than the upper limit of normal), which in the judgement of the local PI would exclude the patient from the trial.*
- •4. Patients taking memantine, amantadine, ketamine, or dextromethorphan.
- •5. Any neurological or major psychiatric diagnosis that may be contributing to cognitive impairment above and beyond that caused by the patients DLB or PDD.
- •6. Renally impaired patients with eGFR <35 mL/min/1.73m².†
- •7. Currently taking part in another clinical trial that would interfere with the outcomes of the COBALT trial.
- •8. If in the opinion of the investigator, the patient would be unable to comply with the trial procedures or has difficulty taking oral medications.
- •9. Patients without a reliable caregiver/informant.
- •*LFTs should be repeated if they were not carried out at screening and were abnormal in the last 6 months and/or, in the judgement of the local PI, are clinically relevant to check before deciding trial entry.
- •†U&Es should be repeated if they were not carried out at screening and were abnormal in the last 6 months and/or, in the judgement of the local PI, are clinically relevant to check before deciding trial entry. For example, a borderline eGRF <45 mL/min/1.73m².
研究者
相似试验
已完成
不适用
Survey of combination of Memantine and methylphenidate among treatment the children with ADHD(Attention-deficit/hyperactivity disorder)Attention deficit hyperactivity disorder.Disturbance of activity and attentionIRCT201208058317N2Research deputy of Ahvaz University of Medical Sciences20
尚未招募
Unknown
To study Memantine as an add-on drug to Escitalopram for Geriatric depression: A double-blind trialCTRI/2024/07/069806Dayanand Medical college and hospital
已完成
2 期
Memantine as an adjunctive therapy to ongoing clozapine treatment: a proof-of-concept study and follow-up studyISRCTN14760638Mental Health Service Organisation North Holland North, Community Mental Health Division52
尚未招募
不适用
A clinical trial to study the effect Of two drugs, oxybutynin and terazocin, on bladder function, in patients of Posterior Urethral Valve after Transurethral FulguratioCTRI/2021/12/038433Postgraduate Institute of Medical Education and Research
已完成
2 期
Pyridostigmine: using a cholinesterase inhibitor to activate the cholinergic anti-inflammatory pathway in patients with CRPS-1pijn syndroomdystrophypost-traumatic dystrophyreflex sympathetic dystrophyNL-OMON33787Vrije Universiteit Medisch Centrum10