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

Neutec Ar-Ge San ve Tic

Status and phase: Unknown; Phase 4

Conditions: Alzheimer Disease; Cognitive Change

Treatments: Combination Product: Ebicomb

Study type: Interventional

Funder types: Industry

Identifiers

NCT03954613

NEU-05.18

Details and patient eligibility

About

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.

Enrollment: 198 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 6 patient groups

Group A

Experimental group

Description:

Donepezil/Memantin Combination

Treatment:

Combination Product: Ebicomb

Group B

Experimental group

Description:

Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)

Treatment:

Combination Product: Ebicomb

Group C

Active Comparator group

Description:

Donepezil Mono

Treatment:

Combination Product: Ebicomb

Group D

Active Comparator group

Description:

Donepezil Mono + Cognitive Exercises (BEYNEX Software)

Treatment:

Combination Product: Ebicomb

Group E

Active Comparator group

Description:

Memantine Mono

Treatment:

Combination Product: Ebicomb

Group F

Active Comparator group

Description:

Memantine Mono + Cognitive Exercises (BEYNEX Software)

Treatment:

Combination Product: Ebicomb