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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03954613
• Other study ID #: NEU-05.18
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2022
• Source: Neutec Ar-Ge San ve Tic A.S
• Contact: Neutec RD
• Phone: 00908502012323
• Email: iremkaraman[@]neutecrdc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Change

Intervention

Combination Product:
• Ebicomb
Combination product and combination product plus cognitive exercises will primarily be evaluated in this study

Locations

Country	Name	City	State
Turkey	Maltepe University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Neutec Ar-Ge San ve Tic A.S

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MOCA total score	MOCA: Montreal - Cognitive Assessment	6-months
Secondary	Change in GDS total score	GDS (The Geriatric Depression Scale)	6-months
Secondary	Change in ADAS-Cog total score	ADAS-Cog: Alzheimer's Disease Assessment Scale- Cognitive Subscale	6-months
Secondary	Change in CDR total score	CDR: The Clinical Dementia Rating	6-months
Secondary	Change in B-ADL total score	B-ADL: The Bayer Activities of Daily Living Scale	6-months
Secondary	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