Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease

Phase 4

• Conditions: Alzheimer Disease; Cognitive Change
• Interventions: Combination Product: Ebicomb

• Registration Number: NCT03954613
• Lead Sponsor: Neutec Ar-Ge San ve Tic A.Ş

Brief Summary

In this study, it is aimed to compare the effects of cognitive exercises applied on long-term internet environment to the cognitive level of patients who received donepezil, memantine or donepezil / memantin combination therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Study Start: 2020-10-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17
• Primary Completion: 2023-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• Patients between 55-90 years old who were diagnosed with Alzheimer's Dementia and had no history of cerebrovascular disease during the last 6 months,
• Patients without other neurodegenerative diseases and secondary dementia diagnoses,
• Patients with MOCA score of between 13-18,
• Patients with at least primary school graduation,
• Patients who have had no CNS disease including trauma in the last year,
• Patients without a diagnosis of psychiatric disease,
• Patients with a tablet or PC with an internet connection,
• Patients agreeing to perform BEYNEX daily activity at least 5 times per week,
• Patients signing informed consent form.

Exclusion Criteria

• Patients who have hypersensitivity to study working drugs,
• Psychotic patients,
• Disabled patients with orthopedic dominant extremity,
• Patients with ICU follow-up due to trauma in the last 6 months,
• Patients with severe visual impairment or eye surgery,
• Patients who refuse to sign the informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group F	Ebicomb	Memantine Mono + Cognitive Exercises (BEYNEX Software)
Group D	Ebicomb	Donepezil Mono + Cognitive Exercises (BEYNEX Software)
Group E	Ebicomb	Memantine Mono
Group A	Ebicomb	Donepezil/Memantin Combination
Group B	Ebicomb	Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)
Group C	Ebicomb	Donepezil Mono

Primary Outcome Measures

Name	Time	Method
Change in MOCA total score	6-months	MOCA: Montreal - Cognitive Assessment

Secondary Outcome Measures

Name	Time	Method
Change in GDS total score	6-months	GDS (The Geriatric Depression Scale)
Change in ADAS-Cog total score	6-months	ADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale
Change in CDR total score	6-months	CDR: The Clinical Dementia Rating
Change in B-ADL total score	6-months	B-ADL: The Bayer Activities of Daily Living Scale
Change in clock drawing test	6-months	The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm) and will be evaluated according to ability to draw.

Trial Locations

Locations (1)

Maltepe University Hospital; 🇹🇷 Istanbul, Turkey