Efficacy and Safety of HimalcaTM on Improvement of Cognitive Function: A 12-week, Prospective, Randomized, Double-blind, Placebo controlled Clinical Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 1. Changes from pre- & post-treatment on mental status and cognitive function assessed by Montreal Cognitive Assessment (MoCA).
Study Overview
Brief Summary
Dementia represents a serious public health challenge for elderly people, while Alzheimer’s disease (AD), the most common type of dementia, has become one of the biggest mental burdens . Except for the recent and controversial approval of Aduhelm to treat patients with Alzheimer’s disease, there are no effective treatments to prevent or delay its progression, only for treating the symptoms of mild to moderate dementia. Therefore, there is an urgent need to identify effective strategies to prevent dementia. It is well recognized that mild cognitive impairment (MCI) precedes AD ; however, new evidence suggests that subtle and silent pathological brain changes associated with subjective decline are also present in subjects with subjective cognitive decline (SCD), defined as a self-reported decline in cognitive performance compared to an individual’s previous level of functioning, which cannot be determined by neuropsychological tests and precedes objective cognitive decline
Mild cognitive impairment (MCI) most simplistically defined refers to cognitive changes in the absence of dementia. It has been likened to an intermediate stage between normalcy and dementia. Indeed, the entity probably stemmed from the pursuit of clinicians to try and find the missing piece of the puzzle between so called “normal†elderly and the elder with dementia.
Reisberg in 1988 first described an entity with Global Deterioration Scale Score (GDS) of 3. Subsequently, Flicker and colleagues wrote an article on patients at risk for dementia, also with GDS scores of 3. Of course, it was Peterson in 1997, who then termed this entity as Mild Cognitive Impairment or MCI.
Currently approved treatment for MCI is purely symptomatic. Registered symptomatic treatment consists of acetylcholinesterase inhibitors (AchE-Is) and memantine. AchE-Is in general.
There is an ongoing effort in the development of more effective symptomatic treatment options, new compounds which are natural extracts with a potential to improve the symptoms of cognitive decline in aging adults are in the center of interest in the research field. However, no natural extract supplement with a robust data has proven the potential to improve the symptoms, restore the cognition and cease the progression into AD is presently available, has been designed to evaluate in improving existing mild cognition deficits and the ability to better perform activities of daily living which would provide a substantial benefit to patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 55.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and Female individuals aged from 55 to 80 years (both inclusive).
- •Those who meet the requirement of Montreal Cognitive Assessment Score of 19 to
- •Literate subjects.
- •Those who voluntarily agree to participate and sign the informed consent form.
Exclusion Criteria
- •Known history of hypersensitivity to any drugs, herbal extracts or dietary supplements.
- •Those with a history of having received any investigational drug or participated in any other clinical trial which ended in the preceding 3 months or are currently ongoing.
- •On-going treatment with herbals or allopathic drugs (cholinesterase inhibitors) for MCI.
- •History of seizures.
- •Head trauma with loss of consciousness.
- •Diagnosed psychiatric disorders including dissociative disorder, obsessive-compulsive disorder, personality disorders, schizophrenia, bipolar disorder.
- •Those consuming drugs amitriptyline, Aripiprazole, Benztropine, Biperiden, Brompheniramine, Carbamazepine, Chlorpheniramine, Chlorpromazine that affect cognitive performance like within 3 months prior to screening.
- •Those who are unable to communicate daily due to impaired vision, hearing, and unable to write due to physical disability.
- •Those who are taking drugs including antihistamine, non-steroid anti-inflammation, hormonal drugs, anti-biotics, etc.
- •Those who have undergone surgery within 6 months prior to screening.
- •Those with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (Angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last 6 months (However, those who are clinically stable may participate in the trial on the investigator’ discretion).
Outcomes
Primary Outcomes
1. Changes from pre- & post-treatment on mental status and cognitive function assessed by Montreal Cognitive Assessment (MoCA).
Time Frame: 1. Baseline and Week 12 | 2. Baseline and Week 12
2. Change from pre- & post-treatment on cognitive function assessed by Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).
Time Frame: 1. Baseline and Week 12 | 2. Baseline and Week 12
Secondary Outcomes
- 1. Change in pre - & post-treatment Brain Derived Neurotrophic Factor.(2. Changes from pre- & post-treatment as assessed by individual tasks in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) including 1) Word Recall, 2) Commands, 3) Constructional Praxis, 4) Naming, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Remembering Word Recognition Test Instructions, 9) Comprehension of Spoken Language, 10) Word-Finding Ability, and 11) Spoken Language Ability.)
Investigators
Dr Guru Prakash K V
Spandana Hospital