Health Condition 1: G300- Alzheimers disease with early onset Health Condition 2: F015- Vascular dementia
Conditions
Interventions
Intervention1: Gaming Platform - COSMA Software from Cerebrum Matter Ltd: 40 Subjects who are randomised into the COSMA Treatment arm will pay the COSMA games on a tablet once a day, everyday for 28
Sponsors
Cerebrum Matter Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Verified neurological evaluation and diagnosis of Mild NeuroCognitive Impairment, Vascular Dementia and/or Dementia associated with Alzheimer’s Disease 2. Neurocognitive evaluation with Functional Assessment Staging Test : Stage 3 to Stage 5 3. Male and female adults less than 65 years of age 4. Subjects who are classified as right handed 5. Subjects who can read and write Tamil and/or English 6. Subjects who can use the provided Android Tablet 7. Subjects with a dedicated LAR or caretaker to address any study objectives in lieu of the subject. 8. Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
Exclusion criteria
Exclusion criteria: 1. Subjects with mental illness and/or neuropsychiatric disorders. 2. Subjects who are on anti-depressants, anti-psychotics and/or medication that may cause worsening in cognitive functions. 3. Subjects with significant primary visual impairments. 4. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation. 5. Subjects who have participated in any clinical study within 3 months from the date of enrolment. 6. Females who are pregnant or lactating or planning to become pregnant or unwilling to use double barrier method during the study period. 7. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 8. Subjects, who in the opinion of the Investigator/CRMC are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Apathy Evaluation Scale: Reduction of =10 scores 2.Trail Marking Test A: Improvement of =5 sec 3.Trail Marking Test B : Improvement = 10 sec 4.Clinical Global Impression: Score of =3 5.32 channel EEG: i.Increase in Alpha and Beta Waves ii.Different brain region activation, shift. 6.CANTAB – Increase of ? 3 Scores 7.COSMA Games i.Time Taken : =25% reduction. ii.No of attempts: =25% reduction. iii.No of correct answers: =25% improvementTimepoint: Apathy Evaluation Scale : Day 1, Day 14, Day 28 Trail Marking Test A : Day 1, Day 14, Day 28 Trail Marking Test B : Day 1, Day 14, Day 28 Clinical Global Impression : Day 28 32 Channel EEG : Day 1, Day 14, Day 28 CANTAB : Day 1, Day 14, Day 28 COSMA GAMES : Day 1, Day 14, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr VTSriraam
Aurous HealthCare Research and Development India Private Limited
Outcome results
None listed