| CTRI Number |
CTRI/2021/05/033644 [Registered on: 17/05/2021] Trial Registered Prospectively |
| Last Modified On: |
14/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to Evaluate the Efficacy and Safety
of L-Serine Supplement along with Standard Treatment in Patients
with Alzheimer’s Disease. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-010-L-SER-2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr HRISHIKESH KUMAR |
| Designation |
HOD, Department Of Neurology, Institute Of Neurosciences kolkata |
| Affiliation |
Institute Of Neurosciences Kolkata |
| Address |
Dept of Neurology, Institute of Neurosciences Kolkata,
185/1 A.J.C. Bose Road, Kolkata 700 017, West Bengal, India
Kolkata
WEST BENGAL
700017
India |
| Phone |
9874645445 |
| Fax |
|
| Email |
rishi_medicine@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUPRIYO CHOUDHURY |
| Designation |
Senior Research Fellow,Department of Neurology,Institute Of Neurosciences Kolkata |
| Affiliation |
Institute Of Neurosciences Kolkata |
| Address |
Dept of Neurology, Institute of Neurosciences Kolkata,
185/1 A.J.C. Bose Road, Kolkata 700 017, West Bengal, India
Kolkata
WEST BENGAL
700017
India |
| Phone |
9433106238 |
| Fax |
|
| Email |
choudhurydrsupriyo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SATTWIKA BANERJEE |
| Designation |
PhD STUDENT,Department of Neurology,Institute Of Neurosciences Kolkata |
| Affiliation |
Institute Of Neurosciences Kolkata |
| Address |
Dept of Neurology, Institute of Neurosciences Kolkata,
185/1 A.J.C. Bose Road, Kolkata 700 017, West Bengal, India
Kolkata
WEST BENGAL
700017
India |
| Phone |
8250201792 |
| Fax |
|
| Email |
sattwikabanerjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| MACLEODS PHARMACEUTICALS LTD. |
|
|
Primary Sponsor
|
| Name |
Institute Of Neurosciences Kolkata |
| Address |
185/1 A.J.C. Bose Road, Kolkata 700 017, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr HRISHIKESH KUMAR |
Institute Of Neurosciences Kolkata |
9th Floor, Research Room, Department of Neurology,185/1 A.J.C. Bose Road, Kolkata 700 017, India.
Kolkata
WEST BENGAL |
9874645445
rishi_medicine@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Neurosciences Kolkata (IEC - I-NK) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G308||Other Alzheimers disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
L-Serine |
Powder for oral solution/15 G per sachet
Dose/Dosing frequency
30 G per day (in two divided dose) for 180 days. |
| Comparator Agent |
Placebo Sachets |
Powder for oral solution/15 G per sachet Dose/Dosing frequency 30 G per day (in two divided dose) for 180 days |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. 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
|
|
| ExclusionCriteria |
| Details |
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 Alzheimer’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 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 |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy Endpoints
• Change in Montreal Cognitive Assessment (MoCA) score at the end of treatment from baseline in both study treatment groups
• Change in clinical dementia rating (CDR) scale score at the end of treatment
Safety Endpoints
• Treatment emergent adverse events (TEAEs) during the study period
• Change in laboratory investigations during the study period
|
Screening visit, Day 0, Day 30, Day 90, Day 150 and Day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in laboratory investigations during the study period
|
Screening visit, Day 0, Day 30, Day 90, Day 150 and Day 180 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/05/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
|