Efficacy and Safety of ChOline ALfoscerate in Patient With Mild to Moderate Alzheimer's Disease

NCT05383183 | Recruiting Phase 4

• 1 other identifier: DWB-CA400
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine whether combination of donepezil, a cholinesterase inhibitor, with choline alfoscerate has a more favourable clinical profile than monotherapy with donepezil alone.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Changes in ADAS-Cog scores

  ADAS-cog change at 12 and 24 weeks from baseline Changes in ADAS-Cog scores at 48 weeks from baseline

  48 weeks from baseline

Secondary Outcomes (5)

• Changes in ADAS-Cog scores

  Time Frame: 12, 24 weeks from baseline

• Changes in ADCOMS scores

  12, 24, and 48 weeks from baseline

• Changes in K-IADL scores

  12, 24, and 48 weeks from baseline

• Changes in CDR-SB scores

  12, 24, and 48 weeks from baseline

• Changes in K-MMSE-2 scores

  12, 24, and 48 weeks from baseline

Study Arms (2)

Choline Alfoscerate 1,200mg + Donepezil 5mg or 10mg

EXPERIMENTAL

Oral administration of choline alfoscerate 400mg TID, donepezil QD (evening) for 48 weeks, no dosage change during trial period

Drug: Choline Alfoscerate 400mg

Placebo + Donepezil 5mg or 10mg

PLACEBO COMPARATOR

Oral administration of placebo TID, donepezil QD (evening) for 48 weeks, no dosage change during trial period

Drug: Placebo

Interventions

Choline Alfoscerate 400mg DRUG

Oral administration

Choline Alfoscerate 1,200mg + Donepezil 5mg or 10mg

Placebo DRUG

Oral administration

Placebo + Donepezil 5mg or 10mg

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ Age ≤ 85 at time of screening
• Diagnosed as a probable Alzheimer Dementia patient according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria
• ≤ K-MMSE-2 score ≤ 26 at time of screening
• ≤ CDR score ≤ 2 at time of screening
• Administration of donepezil 5 mg or 10 mg without dose change for at least 3 months at time of screening
• Ability to walk or to move using a walking aid (i.e. senior walker, cane, or wheelchair)
• Presence of a caregiver who regularly spends time with the patient and can accompany the patient to hospital visits
• \- The caregiver must spend at least 8 hours per week with the patient
• The caregiver should be able to supervise trial compliance and report subject status to the investigator
• Sufficient visual acuity, hearing, language ability, motor function and comprehension, as judged by the investigator, to follow the examination procedure (auxiliary devices such as glasses and hearing aids are permitted)
• Voluntarily decision to participate in this clinical trial from both the subject and the subject's legal representative
• ≤ K-MMSE-2 score ≤ 26 at time of randomization
• Compliance with donepezil ≥ 80% during run-in

You may not qualify if:

• Dementia due to other causes including:
• \- Probable vascular dementia according to NINDS-AIREN criteria
• Infection of the central nervous system (eg HIV, syphilis, etc.)
• Head trauma
• Creutzfeld-Jacob disease
• Pixie's disease
• Huntington's disease
• Parkinson's disease
• Drug addiction and/or Alcoholism
• Patients with other major structural brain diseases (strategic cerebral infarction, subdural hematoma, traffic hydrocephalus, brain tumor) and/or evidence (CT or MRI results performed within the past 12 months or at screening) as the cause of dementia (provided that (Excluding lacunar cerebral infarction with a diameter of less than 1 cm in the area judged not to be related to cognitive function)
• ≤ New Rating Scale for ARWMC (Age-Related White Matter Changes) score within 12 months of screening
• Myocardial infarction, unstable angina pectoris, orthostatic hypotension or unexplained syncope within 12 months of screening, hospitalization for arrhythmia, or moderate to severe congestive heart failure (NYHA class III or IV), clinically Patients with significant structural heart disease (valvular disease, hypertrophic cardiomyopathy)
• Serious mental disorders such as severe depression, schizophrenia, alcoholism, and drug dependence
• History of malignant tumor within 5 years of screening. (However, enrollment is allowed if any of the following applies:)
• More than 5 years since completion of treatment for tumor

Sponsors & Collaborators

• Daewoong Bio Inc.: lead

Study Sites (4)

Changwon Fatima Hospital

Changwon, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, South Korea

RECRUITING

CHA Bundang Medical Center

Seongnam, South Korea

RECRUITING

The Catholic University of Korea Seoul ST.MARY'S Hospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Glycerylphosphorylcholine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glycerophosphates; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Glycerophospholipids; Phosphatidic Acids; Phospholipids; Membrane Lipids; Lipids; Lecithins; Phosphatidylcholines

Central Study Contacts

Yunjae Ahn

CONTACT

+82-550-8191; yjahn@daewoong-bio.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: May 20, 2022
• Study Start: January 20, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 9, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

KR (4)