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

Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease Receiving Donepezil, Memantine or Donepezil/Memantine Combination Therapy: Open-Labeled, Randomized, Phase IV, Superiority Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Change; Alzheimer Disease
• Intervention / Treatment: Combination product: Ebicomb

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Neutec RD; Phone Number: 0000 00908502012323; Email: iremkaraman@neutecrdc.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Maltepe University Hospital
    • Contact: Nilgün Çınar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Donepezil/Memantin Combination	Combination product: Ebicomb; Combination product and combination product plus cognitive exercises will primarily be evaluated in this study; Other Names: Donepezil-Memantine
Experimental: Group B; Donepezil/Memantin Combination + Cognitive Exercises (BEYNEX Software)	Combination product: Ebicomb; Combination product and combination product plus cognitive exercises will primarily be evaluated in this study; Other Names: Donepezil-Memantine
Active Comparator: Group C; Donepezil Mono	Combination product: Ebicomb; Combination product and combination product plus cognitive exercises will primarily be evaluated in this study; Other Names: Donepezil-Memantine
Active Comparator: Group D; Donepezil Mono + Cognitive Exercises (BEYNEX Software)	Combination product: Ebicomb; Combination product and combination product plus cognitive exercises will primarily be evaluated in this study; Other Names: Donepezil-Memantine
Active Comparator: Group E; Memantine Mono	Combination product: Ebicomb; Combination product and combination product plus cognitive exercises will primarily be evaluated in this study; Other Names: Donepezil-Memantine
Active Comparator: Group F; Memantine Mono + Cognitive Exercises (BEYNEX Software)	Combination product: Ebicomb; Combination product and combination product plus cognitive exercises will primarily be evaluated in this study; Other Names: Donepezil-Memantine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MOCA total score	MOCA: Montreal - Cognitive Assessment	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in GDS total score	GDS (The Geriatric Depression Scale)	6-months
Change in ADAS-Cog total score	ADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale	6-months
Change in CDR total score	CDR: The Clinical Dementia Rating	6-months
Change in B-ADL total score	B-ADL: The Bayer Activities of Daily Living Scale	6-months
Change in clock drawing test	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.	6-months

Collaborators and Investigators

• Sponsor: Neutec Ar-Ge San ve Tic A.Ş
• Investigators: Study Chair: Türker Şahiner, Prof Dr, Project Consultant

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Alzheimer Disease; Combination; Donepezil; Internet; Cognitive Exercises; Memantin
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Nootropic Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Cholinesterase Inhibitors; Donepezil; Memantine
• Other Study ID Numbers: NEU-05.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No