A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Patients With Mild to Moderate Alzheimer's Disease
Overview
- Phase
- Phase 4
- Intervention
- Choline Alfoscerate 400mg
- Conditions
- Alzheimer Disease
- Sponsor
- Daewoong Bio Inc.
- Enrollment
- 630
- Locations
- 4
- Primary Endpoint
- Changes in ADAS-Cog scores
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Detailed Description
Aging population is a characteristic feature of demographic trends in developed countries. Hence, Alzheimer's disease is recognized as one of today's major healthcare challanges, and its significance will increase even more as the longevity of the population increases. Pre-clinical investigations have suggested that association between ChE-Is (cholinesterase inhibitors) and the cholinergic precursor choline alfoscerate enhances cholinergic neurotransmission more effectively than single compounds alone. This clinical trial is designed to assess if combination of the ChE-I donepezil with choline alfoscerate has a more favorable clinical profile than monotherapy with donepezil alone.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\<Screening Inclusion Criteria\>
- •50 ≤ 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
- •10 ≤ K-MMSE-2 score ≤ 26 at time of screening
- •0.5 ≤ 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
Exclusion Criteria
- •\<Screening Exclusion Criteria\>
- •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
Arms & Interventions
Choline Alfoscerate 1,200mg + Donepezil 5mg or 10mg
Oral administration of choline alfoscerate 400mg TID, donepezil QD (evening) for 48 weeks, no dosage change during trial period
Intervention: Choline Alfoscerate 400mg
Placebo + Donepezil 5mg or 10mg
Oral administration of placebo TID, donepezil QD (evening) for 48 weeks, no dosage change during trial period
Intervention: Placebo
Outcomes
Primary Outcomes
Changes in ADAS-Cog scores
Time Frame: 48 weeks from baseline
ADAS-cog change at 12 and 24 weeks from baseline Changes in ADAS-Cog scores at 48 weeks from baseline
Secondary Outcomes
- 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 ADAS-Cog scores(Time Frame: 12, 24 weeks from baseline)
- Changes in K-MMSE-2 scores(12, 24, and 48 weeks from baseline)
- Changes in ADCOMS scores(12, 24, and 48 weeks from baseline)