Clinical Trial on Early-Stage Memory Loss (mild cognitive impairment) in Adults Aged 50-70 Years

Phase 3

• Registration Number: CTRI/2024/07/071190
• Lead Sponsor: Katra Phytochem (India) Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Adult male and female subjects aged between 50-70 years old complaining of memory impairment.

2 Subjects with a Hindi Mental State Examination (HMSE) score between 20 to 26.

3 Must be willing and able to give informed consent and comply with the study procedures

Exclusion Criteria

1 Subjects with a diagnosis of dementia as per the Diagnostic and Statistical Manual of Mental Disorders (DSM 5).

2 Subjects with a diagnosis of attention deficit hyperactivity disorder (ADHD) as per the Diagnostic and Statistical Manual of Mental Disorders (DSM 5).

3 Subjects who are currently undergoing exercise therapy or dietary therapy.

4 Subjects with cognitive impairment due to organic brain disease or mental or psychiatric illness.

5 Subjects with a Hospital Anxiety and Depression Scale (HADS) depression subscale score of greater than7.

6 Subjects with a Hospital Anxiety and Depression Scale (HADS) anxiety subscale score of greater than7.

7 Subjects with an Insomnia Severity Index (ISI) score of greater than 7.

8 Subjects with an Alcohol Use Disorders Identification Test (AUDIT) score of greater than 3.

9 Subjects with a history of antipsychotic medication use within the 3 months preceding the screening visit.

10 Subjects who are currently on or were in the past 4 weeks preceding the screening visit on any medications which could impair cognitive functions such as anticholinergic medications (diphenhydramine, atropine); benzodiazepines (alprazolam, lorazepam, and diazepam); antipsychotic medications (risperidone, olanzapine, and quetiapine); antiepileptic drugs (topiramate, levetiracetam, and phenytoin); antihypertensive medications (amlodipine, beta-blockers, and diuretics); opioids (codeine, oxycodone, and hydrocodone); antihistamines (diphenhydramine, chlorpheniramine, and cetirizine); nortriptyline).

11 Subjects who have received treatment with any approved or investigational health supplement(s) for improvement of cognition and memory within the past 1 month preceding the screening visit.

12 Subjects whose neuropsychological tests indicate a suspected diagnosis of dementia.

13 Subjects with a history of any traumatic brain injury with loss of consciousness or convulsion.

14 Subjects with uncontrolled blood pressure, diabetes mellitus, or hypothyroidism.

15 Subjects with abnormal laboratory test findings such as:

AST and ALT greater than 3 times the upper limit of normal

Hb less than or equal to 8 g/dL

Platelet count lessthan100000/mm3

16 Subjects with serum creatine greater than 3 times the upper limit of normal or with acute or chronic renal failure requiring dialysis.

17 Subjects participating in another clinical trial within the 3 months preceding the screening visit.

18 Subjects with severe hearing and vision impairment for whom efficacy evaluation cannot be conducted.

19 Subjects with any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments.

20 Subjects with any underlying clinically significant disease that, in the view of the investigator, will substantially impact the subject’s overall well-being including conditions affecting the cardiovascular, endocrine, immune, respiratory, kidney and urinary, neuropsychiatric, musculoskeletal, inflammatory, blood, as well as gastrointestinal diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified