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

Phase 2

• Conditions: Health Condition 1: G300- Alzheimers disease with early onsetHealth Condition 2: F015- Vascular dementia

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Verified neurological evaluation and diagnosis of Mild NeuroCognitive Impairment, Vascular Dementia and/or Dementia associated with Alzheimerââ?¬•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.

8.Subjects, who in the opinion of the Investigator/CRMC are not eligible for enrolment in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified