A Clinical Trial to Evaluate the Efficacy and Safetyof L-Serine Supplement along with Standard Treatment in Patientswith Alzheimer’s Disease.

Not yet recruiting

• Conditions: Other Alzheimers disease,

• Registration Number: CTRI/2021/05/033644
• Lead Sponsor: Institute Of Neurosciences Kolkata

Brief Summary

Title- A Prospective, Randomized, Double-blind, Placebo-Controlled Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of L-Serine Supplement along with Standard Treatment in Patients with Alzheimer’s Disease

Objective- To evaluate the clinical efficacy and safety of L-serine supplements in patients with Alzheimer’s Disease

Study.

Total 60 Male and non-pregnant female patients who are aged 45 to 75 (both ages inclusive) with clinical diagnosis of AD consistent with criteria from DSM V will be considered for participating in the study.

The study includes screening period (up to 14 days), treatment period (180 days), and 14-day safety follow-up period after the last dose of study treatment.

clinical trials in human investigating the therapeutic effects of L-serine support the determination that L-serine is generally regarded as safe (GRAS); it also appears to be neuroprotective. This clinical trial is planned to study the effects of L-serine supplement along with standard supportive care in patients with AD.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-05-14
• Study Start: 2021-05-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male or female patients aged between 45 to 75 years of age both ages inclusive 2.
• Patients with clinical diagnosis of Alzheimer’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 patient’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.

Exclusion Criteria

• 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 Alzheimer’s disease 12.
• Patients who in the opinion of the investigator are otherwise unsuitable for this study.
• 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 Huntington’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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy Endpoints	Screening visit, Day 0, Day 30, Day 90, Day 150 and Day 180
•Change in Montreal Cognitive Assessment (MoCA) score at the end of treatment from baseline in both study treatment groups	Screening visit, Day 0, Day 30, Day 90, Day 150 and Day 180
•Treatment emergent adverse events (TEAEs) during the study period	Screening visit, Day 0, Day 30, Day 90, Day 150 and Day 180
•Change in laboratory investigations during the study period	Screening visit, Day 0, Day 30, Day 90, Day 150 and Day 180
•Change in clinical dementia rating (CDR) scale score at the end of treatment	Screening visit, Day 0, Day 30, Day 90, Day 150 and Day 180
Safety Endpoints	Screening visit, Day 0, Day 30, Day 90, Day 150 and Day 180

Secondary Outcome Measures

Name	Time	Method
Change in laboratory investigations during the study period

Trial Locations

Locations (1)

Institute Of Neurosciences Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Institute Of Neurosciences Kolkata

🇮🇳Kolkata, WEST BENGAL, India

Dr HRISHIKESH KUMAR

Principal investigator

9874645445

rishi_medicine@yahoo.com