A Clinical Trial to Evaluate the Efficacy and Safetyof L-Serine Supplement along with Standard Treatment in Patientswith Alzheimerâ??s Disease.
- Conditions
- Health Condition 1: G308- Other Alzheimers disease
- Registration Number
- CTRI/2021/05/033644
- Lead Sponsor
- Institute Of Neurosciences Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Endpoints <br/ ><br>â?¢Change in Montreal Cognitive Assessment (MoCA) score at the end of treatment from baseline in both study treatment groups <br/ ><br>â?¢Change in clinical dementia rating (CDR) scale score at the end of treatment <br/ ><br>Safety Endpoints <br/ ><br>â?¢Treatment emergent adverse events (TEAEs) during the study period <br/ ><br>â?¢Change in laboratory investigations during the study period <br/ ><br>Timepoint: 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 <br/ ><br>Timepoint: Screening visit, Day 0, Day 30, Day 90, Day 150 and Day 180