Alzheimer Disease
Conditions
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.
Interventions
Oral administration
DRUGPlacebo
Oral administration
Sponsors
Daewoong Bio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
\<Screening Inclusion Criteria\> 1. 50 ≤ Age ≤ 85 at time of screening 2. 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 3. 10 ≤ K-MMSE-2 score ≤ 26 at time of screening 4. 0.5 ≤ CDR score ≤ 2 at time of screening 5. Administration of donepezil 5 mg or 10 mg without dose change for at least 3 months at time of screening 6. Ability to walk or to move using a walking aid (i.e. senior walker, cane, or wheelchair) 7. 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 8. 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) 9. Voluntarily decision to participate in this clinical trial from both the subject and the subject's legal representative \<Randomization Inclusion Criteria\> 1. 10 ≤ K-MMSE-2 score ≤ 26 at time of randomization 2. Compliance with donepezil ≥ 80% during run-in
Exclusion criteria
\<Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in ADAS-Cog scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in ADCOMS scores | 12, 24, and 48 weeks from baseline | Changes in ADCOMS scores at 12, 24 and 48 weeks from baseline |
| Changes in K-IADL scores | 12, 24, and 48 weeks from baseline | Changes in K-IADL scores at 12, 24 and 48 weeks from baseline |
| Changes in CDR-SB scores | 12, 24, and 48 weeks from baseline | Changes in CDR-SB scores at 12, 24 and 48 weeks from baseline |
| Changes in ADAS-Cog scores | Time Frame: 12, 24 weeks from baseline | Changes in ADAS-Cog scores at 12, 24 weeks from baseline |
| Changes in K-MMSE-2 scores | 12, 24, and 48 weeks from baseline | Changes in K-MMSE-2 scores at 12, 24 and 48 weeks from baseline |
Countries
South Korea
Contacts
Primary ContactYunjae Ahn
Outcome results
None listed