Clinical Study to Test Effectiveness of COSMA Gaming Software on Dementia Patients

Phase 2

Completed

• Conditions: Alzheimers disease with early onset, (2) ICD-10 Condition: F015||Vascular dementia,

• Registration Number: CTRI/2019/10/021800
• Lead Sponsor: Cerebrum Matter Limited

Brief Summary

**Study Design :** An Open Label, Prospective, Randomised, Comparative, Two Arm Clinical Study

**Indication:** Mild NeuroCognitive Impairment, Vascular Dementia and/or Dementia associated with Alzheimer’s Disease

**Subject Population:** 60 Subjects - Male and female adults less than 65 years of age diagnosed with Mild NeuroCognitive Impairment, Vascular Dementia and/or Dementia associated with Alzheimer’s Disease (Stage 3 to Stage 5 as per Functional Assessment Staging Test)

**Investigational Device :**  Gaming Platform : COSMA Software from Cerebrum Matter Ltd.

**Treatment Arms :**

**- Treatment Arm I : COSMA Players :** 40 Subjects who play the games everyday for 28 days.

- **Treatment Arm II : Control Players :** 20 Subjects who will play the games only for 3 days (Day 1, Day 14, Day 28)

**Assessments:**

1. Edinburgh Handedness Questionnaire : Screening

2. MRI for Diagnosis : Screening

3. FAST : Screening

4. COSMA Games + 32 Channel EEG : Day 1. Day 14, Day 28

5. CANTAB :  Day 1. Day 14, Day 28

6. Apathy Evaluation Scale :  Day 1. Day 14, Day 28

7. Trail Marking Test A & B :  Day 1. Day 14, Day 28

8. Clinical Global Impression Scale : Day 28

9. COSMA Usability Feedback Form : Day 28 **Results** Digital Therapy with COSMA for the minimum of 28 days, has helpedSubjects with MCI greatly in improving their sense of apathy and combat loss ofinterest.

With COSMA, Subjects with MCI were able toreduce the time taken for Trail Marking Test : A from 4 minutes 12 seconds to 2minutes 20 seconds in just 28 days. There was no improvement seen in the subjects who acted as Control. This amounts to an improvement of 46.48% inTrail Marking Test A with 28 days of COSMA.

With COSMA, Subjects with MCI were able toreduce the time taken for Trail Marking Test : B from 4 minutes 57 seconds to 3minutes 33 seconds in just 28 days. There was no improvement seen in the subjects who acted as Control. This amounts to an improvement of 35.96% inTrail Marking Test B with 28 days of COSMA.

After 28 days of COSMA, the Clinician assessedthe MCI patients to be “much improved†compared to baseline, while subjectsdeemed controlled were assessed to be minimally worse.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-11
• Study Completion: 2020-03-02
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Apathy Evaluation Scale: Reduction of ≥10 scores	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
i.Increase in Alpha and Beta Waves	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
ii.Different brain region activation, shift.	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
2.Trail Marking Test A: Improvement of ≥5 sec	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
5.32 channel EEG:	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
3.Trail Marking Test B : Improvement ≥ 10 sec	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
6.CANTAB – Increase of  3 Scores	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
7.COSMA Games	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
i.Time Taken : ≥25% reduction.	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
ii.No of attempts: ≥25% reduction.	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
iii.No of correct answers: ≥25% improvement	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
4.Clinical Global Impression: Score of ≤3	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

Trial Locations

Locations (3)

Bangalore Neuro Centre; 🇮🇳 Bangalore, KARNATAKA, India

Memory Clinic; 🇮🇳 Chennai, TAMIL NADU, India

Raam Clinic; 🇮🇳 Chennai, TAMIL NADU, India

Bangalore Neuro Centre

🇮🇳Bangalore, KARNATAKA, India

Dr Gopukumar Kumarpillai

Principal investigator

8762687741

gopukumar@yahoo.com