Moderate to Severe Alzheimer's Disease Clinical Trial
Official title:
Donepezil and Memantine in Moderate to Severe Alzheimer's Disease
The trial will examine whether pharmacological treatment with donepezil, memantine or
combination of memantine and donepezil is any better than a placebo (dummy) treatment in
people with Alzheimer's disease who have reached the moderate to severe stage of illness.
Using a double blind design, where neither the investigators nor participants know who is
receiving which treatment, participants will be randomly assigned to one of these four
treatment groups (donepezil and memantine, memantine only, donepezil only or placebo). In
order to keep both the investigators and participants blind to drug allocation a double
dummy design will be necessary. This means that each participant will receive 2 treatments −
either an active form or placebo of each of the 2 study drugs.
Hypotheses are:
1. Patients with Alzheimer's disease (AD) who continue donepezil beyond the point of
transition from moderate to severe dementia continue to show significantly less decline
on ratings of cognitive function and activities of daily living over the following 12
months than those discontinuing donepezil.
2. Patients with AD who change to memantine therapy in place of donepezil at the point of
transition from moderate to severe dementia show significantly smaller decline on
ratings of cognitive function and activities of daily living over the following 12
months than those who receive placebo.
3. Patients given the combination of memantine and donepezil at the point of transition
from moderate to severe dementia show significant additive or synergistic benefits on
measures of activities of daily living and cognitive function after 12 months compared
to those patients continuing on either drug as a single treatment.
This trial will involve the withdrawal of drug participants that are currently on (donepezil) and in arm 4, the participant will only be on placebo treatment. It is important to include this arm of the study as a key objective in looking at the benefit of continuing donepezil and therefore a placebo arm should be present as a comparator. To reduce the risk to participants of withdrawing donepezil too early in their illness, an inclusion criteria is that the participant is at a stage in their disease whereby the prescribing clinician feels a change in drug prescription may be appropriate. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05303701 -
GV1001 Subcutaneous for the Treatment of Moderate to Severe Alzheimer's Disease(AD)
|
Phase 3 |