CTRI/2021/05/033644尚未招募未知
A Prospective, Randomized, Double-blind, Placebo-ControlledProof-of-concept Clinical Study to Evaluate the Efficacy and Safetyof L-Serine Supplement along with Standard Treatment in Patientswith Alzheimerâ??s Disease.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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
入选标准
- •1. Male or female patients aged between 45 to 75 years of age both ages inclusive
- •2. Patients with clinical diagnosis of Alzheimerâ??s disease; based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revision criteria DSM V
- •3. Patients diagnosed with Alzheimer disease as scored by the Clinical Dementia Rating Scale score of 0.5 within the 6 months prior to randomization day
- •4. Mini-Mental State Examination MMSE score in between 11 to 26 in case of mild to moderate stage of AD
- •5. Patients must be receiving cholinesterase inhibitor medications and/or N-methyl-D-aspartate (NMDA) receptor antagonist medications and must be on a stable dose of these medications for at least 1 month prior to randomization day
- •6. Clinically assessed absence of major depressive disease
- •7. Women of childbearing potential must be willing to consistently use an appropriate and adequate method of contraception
- •8. Previous decline in cognition for more than six months as documented in patients medical records
- •9. General health status of patient acceptable for participation in current clinical trial
- •10. Patients with any other chronic conditions are stable and undergoing appropriate treatment
- •11. Study partner, patient and patientâ??s legally acceptable representative (LAR) must understand and have signed an informed consent form to participate in this study
- •12. Study partner and patient must be able to read and understand study requirements and be willing to follow instructions, attend all required study visits, and undergo all planned tests
排除标准
- •1. History of or screening brain MRI scan indicative of significant abnormality including but not limited to prior hemorrhage or infarct more than 1 cm3 more than 3 lacunar infarcts cerebral contusion astrocytoma encephalomalacia aneurysm vascular malformation subdural hematoma hydrocephalus space occupying lesion eg abscess or brain tumor such as meningioma or oligodendroma
- •2. Patients with MMSE score of less than 10
- •3. Known hypersensitivity to active and inactive ingredients of study treatment
- •4. Patients with cause of dementia other than Alzheimers disease
- •5. Diagnosis or previous history of psychiatric illness that in the investigators opinion would affect the patients ability to successfully participate in the study e.g. active major depression schizophrenia or bipolar disorder
- •6. Clinical or laboratory findings consistent with a Other primary degenerative dementia b Other neurodegenerative condition
- •7. Patients with known or suspected history of drug or alcohol misuse as per Investigators discretion
- •8. Patients receiving supplements or alternative therapies containing acetylcholine precursors putative memory enhancers insulin and psychotropic drugs
- •9. Patients receiving small doses of short acting benzodiazepines chloral hydrate or haloperidol during the study or 1 month prior to study
- •10. Patients with history of myocardial infarction uncompensated congestive heart failure New York Heart Classification III IV or uncontrolled hypertension diabetes mellitus
- •11. Patients who are or have currently participating in a clinical trial with an investigational drug for Alzheimerâ??s disease
- •12. Patients who in the opinion of the investigator are otherwise unsuitable for this study.
- •13. Clinically significant serious advanced or unstable disease that may interfere with outcome measures and which may bias the assessment of the clinical or mental status of the patient or put the patient at special risk
- •14. Female patients who are pregnant or breast feeding or planning to be pregnant
- •15. Participation in another clinical trial within 3 months before screening
- •16. Patients who have participated in a clinical trial investigating AD in past 6 months prior to randomization
- •17. History or evidence of any medical or neurological condition that could impact on the cognition or on the performance of the participant on cognitive assessments in the opinion of Investigator eg Huntingtonâ??s disease Parkinsons disease Lyme disease, schizophrenia bipolar disorder active seizure disorder history of multiple traumatic brain injuries
- •19. History or evidence of a medical surgical condition that may interfere with the safety tolerability and or study assessments of the clinical trial and or put the participant at special risk or compromise safety of the patient
- •19. Known history of human immunodeficiency virus infection hepatitis B or C virus infections
研究者
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