CLINICAL TRIALS PROFILE FOR MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

All Clinical Trials for Memantine Hydrochloride And Donepezil Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00154635 ↗	Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease	Unknown status	Development Center for Biotechnology, Taiwan	Phase 2	2005-09-01	A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients with Mild to Moderate Alzheimer's Disease. Because of the limitation of the sample size we could expect but a positive trend of the efficacy unless the effect size of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical investigation such as a phase III study should be carried out in an even larger scale. We also should be able to obtain valuable experience on the adverse effect of prolonged (24-week) use of Fo-ti.
NCT00154635 ↗	Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease	Unknown status	Program Office, National Science & Technology, Biotechnology & Pharmaceuticals	Phase 2	2005-09-01	A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients with Mild to Moderate Alzheimer's Disease. Because of the limitation of the sample size we could expect but a positive trend of the efficacy unless the effect size of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical investigation such as a phase III study should be carried out in an even larger scale. We also should be able to obtain valuable experience on the adverse effect of prolonged (24-week) use of Fo-ti.
NCT00154635 ↗	Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease	Unknown status	Taipei Veterans General Hospital, Taiwan	Phase 2	2005-09-01	A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients with Mild to Moderate Alzheimer's Disease. Because of the limitation of the sample size we could expect but a positive trend of the efficacy unless the effect size of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical investigation such as a phase III study should be carried out in an even larger scale. We also should be able to obtain valuable experience on the adverse effect of prolonged (24-week) use of Fo-ti.
NCT00154635 ↗	Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease	Unknown status	National Taiwan University Hospital	Phase 2	2005-09-01	A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients with Mild to Moderate Alzheimer's Disease. Because of the limitation of the sample size we could expect but a positive trend of the efficacy unless the effect size of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical investigation such as a phase III study should be carried out in an even larger scale. We also should be able to obtain valuable experience on the adverse effect of prolonged (24-week) use of Fo-ti.
NCT00181298 ↗	Memantine in Systemic Lupus Erythematosus	Completed	Forest Laboratories	N/A	2006-03-01	Neuropsychiatric manifestations of Systemic Lupus Erythematosus (NPSLE) are both common and an important source of morbidity. Of the case definitions for NPSLE syndromes that have recently been developed, cognitive dysfunction appears to be the most prevalent. A novel mechanism is that a subset of SLE patients with cognitive dysfunction have antibodies in the NR2 glutamate receptor. We propose, in a double -blind placebo-controlled trial, to determine whether SLE patients, with or without the NR2 glutamate receptor antibody, have significant improvement using memantine, an inhibitor of the NMDA receptor.

Clinical Trial Conditions for Memantine Hydrochloride And Donepezil Hydrochloride

Condition Name

Condition Name for Memantine Hydrochloride And Donepezil Hydrochloride
Intervention	Trials
Alzheimer's Disease	10
Alzheimer Disease	5
Dementia	3
Mild Cognitive Impairment	2

Condition MeSH

Condition MeSH for Memantine Hydrochloride And Donepezil Hydrochloride
Intervention	Trials
Alzheimer Disease	19
Dementia	5
Cognitive Dysfunction	2
Lewy Body Disease	1

Clinical Trial Locations for Memantine Hydrochloride And Donepezil Hydrochloride

Trials by Country

Trials by Country for Memantine Hydrochloride And Donepezil Hydrochloride
Location	Trials
United States	93
Spain	6
Canada	5
France	4
United Kingdom	4

Trials by US State

Trials by US State for Memantine Hydrochloride And Donepezil Hydrochloride
Location	Trials
North Carolina	5
Massachusetts	5
Florida	5
California	5
New York	5

Clinical Trial Progress for Memantine Hydrochloride And Donepezil Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Memantine Hydrochloride And Donepezil Hydrochloride
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	5
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Memantine Hydrochloride And Donepezil Hydrochloride
Clinical Trial Phase	Trials
Completed	17
Unknown status	3
Recruiting	3

Clinical Trial Sponsors for Memantine Hydrochloride And Donepezil Hydrochloride

Sponsor Name

Sponsor Name for Memantine Hydrochloride And Donepezil Hydrochloride
Sponsor	Trials
Forest Laboratories	4
Johns Hopkins University	2
DSM Nutritional Products, Inc.	1

Sponsor Type

Sponsor Type for Memantine Hydrochloride And Donepezil Hydrochloride
Sponsor	Trials
Other	27
Industry	15
U.S. Fed	3

Memantine Hydrochloride and Donepezil Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Memantine hydrochloride and donepezil hydrochloride are two medications commonly used in the treatment of Alzheimer's disease and other forms of dementia. This article provides an update on the clinical trials, market analysis, and projections for the combination of these drugs.

Mechanism of Action

Donepezil Hydrochloride

Donepezil is a cholinesterase inhibitor that works by increasing the levels of acetylcholine, a neurotransmitter crucial for memory and cognitive function, in the brain. This action helps to improve or stabilize symptoms related to memory loss, confusion, and cognitive decline in patients with mild to moderate Alzheimer’s disease[2].

Memantine Hydrochloride

Memantine is an N-methyl-D-aspartate (NMDA) receptor antagonist. It blocks the action of glutamate, a neurotransmitter that can be toxic to nerve cells in high amounts, thereby protecting the brain cells from damage. This mechanism is particularly beneficial in treating moderate to severe Alzheimer’s disease[5].

Clinical Trials Update

Combination Therapy

The combination of memantine hydrochloride and donepezil hydrochloride, known as Namzaric, has been extensively studied. Clinical trials have shown that this combination is effective in treating moderate to severe Alzheimer’s disease. The FDA approved Namzaric in 2014 for this indication, with recommended doses of 28 mg memantine and 10 mg donepezil (or 14 mg memantine and 10 mg donepezil for patients with severe renal impairment)[5].

Efficacy Outcomes

Studies have demonstrated that the combination of memantine and donepezil improves cognitive function and behavioral symptoms in patients with Alzheimer’s disease. For instance, a meta-analysis showed that donepezil at 10 mg/day significantly improved MMSE (Mini-Mental State Examination) scores, indicating better cognitive function. When combined with memantine, this effect is often enhanced, particularly in reducing behavioral and psychological symptoms[1].

Ongoing and Future Trials

Several ongoing and planned clinical trials are investigating the efficacy and safety of memantine and donepezil in various patient populations. These trials aim to further elucidate the benefits and potential side effects of this combination therapy. For example, trials are exploring the use of this combination in different stages of Alzheimer’s disease and in combination with other therapeutic agents[4].

Market Analysis

Market Size and Growth

The global market for Alzheimer’s therapeutics, including memantine and donepezil, is projected to grow significantly. The donepezil market alone was valued at $0.9 billion in 2023 and is expected to reach $1.1 billion by 2033, growing at a CAGR of 1.9% from 2024 to 2033. This growth is driven by the increasing prevalence of Alzheimer’s disease, rising geriatric populations, and the growing demand for effective cognitive-enhancing treatments[2].

Market Segmentation

The market is segmented by drug type, with memantine hydrochloride and donepezil hydrochloride being key players. The combination product, Namzaric, holds a significant share due to its efficacy in treating moderate to severe Alzheimer’s disease. Geographically, North America has a significant market share due to advanced healthcare infrastructure and significant investment in research and development. The Asia-Pacific region is expected to exhibit the fastest growth rate during the forecast period[2].

Key Players and Competitive Strategies

Major pharmaceutical companies such as Pfizer, Novartis, AstraZeneca, Eli Lilly, and Merck are key players in the Alzheimer’s therapeutics market. These companies are focusing on developing novel therapies and combination treatments to address the unmet needs in Alzheimer’s disease management. The competitive landscape is further influenced by pipeline analysis, which includes Phase III drugs and other potential treatments in development[3].

Market Projections

Increasing Demand

The demand for Alzheimer’s therapies, including memantine and donepezil, is expected to surge due to the escalating prevalence of Alzheimer’s disease. According to the CDC, the prevalence of Alzheimer’s disease among Americans is projected to increase from 6.7 million in 2023 to 14 million by 2060. This trend underscores the urgent need for effective treatments and interventions[2].

Regional Growth

The Asia-Pacific region is anticipated to exhibit the fastest growth rate during the forecast period, driven by increasing healthcare expenditure, growing awareness of personalized medicine, and an expanding biotechnology sector. Countries like China and Japan are at the forefront, with substantial investments in genomic research and a rise in the number of biotech startups[2].

Pipeline Analysis

The pipeline for Alzheimer’s therapeutics includes several potential drugs in various stages of development. Phase III drugs, such as ENA713 and Flutemetamol (18F), are expected to contribute significantly to the market growth once approved. The current unmet needs in Alzheimer’s disease management represent a huge opportunity for pharmaceutical companies developing targeted novel therapies[3].

Key Takeaways

• The combination of memantine hydrochloride and donepezil hydrochloride is effective in treating moderate to severe Alzheimer’s disease.
• Clinical trials have shown significant improvements in cognitive function and behavioral symptoms with this combination therapy.
• The global market for these drugs is projected to grow, driven by the increasing prevalence of Alzheimer’s disease and rising geriatric populations.
• North America and the Asia-Pacific region are key markets, with the latter expected to exhibit the fastest growth rate.
• Pharmaceutical companies are focusing on developing novel therapies and combination treatments to address unmet needs in Alzheimer’s disease management.

FAQs

What is the mechanism of action of memantine hydrochloride and donepezil hydrochloride?

Memantine hydrochloride is an NMDA receptor antagonist that blocks the action of glutamate, protecting brain cells from damage. Donepezil hydrochloride is a cholinesterase inhibitor that increases the levels of acetylcholine in the brain, improving cognitive function.

What is the approved combination product of memantine and donepezil?

The approved combination product is Namzaric, which contains memantine hydrochloride extended release (ER) and donepezil hydrochloride.

What are the projected market growth and size for donepezil?

The donepezil market was valued at $0.9 billion in 2023 and is projected to reach $1.1 billion by 2033, growing at a CAGR of 1.9% from 2024 to 2033.

Which regions are expected to drive the growth of the Alzheimer’s therapeutics market?

North America has a significant market share, but the Asia-Pacific region is expected to exhibit the fastest growth rate during the forecast period.

What are the key drivers of the market growth for memantine and donepezil?

The key drivers include the increasing prevalence of Alzheimer’s disease, rising geriatric populations, and the growing demand for effective cognitive-enhancing treatments.

Sources

1. Frontiers in Neuroscience: "Efficacy of 5 and 10 mg donepezil in improving cognitive function in patients with dementia: A systematic review and meta-analysis"[1].
2. Allied Market Research: "Donepezil Market Size, Share, Trends & Growth Statistics, 2033"[2].
3. Business Wire: "Alzheimers Therapeutic Global Market Report 2022 - Featuring Pfizer, Novartis, AstraZeneca, Eli Lilly, Merck, Acadia, More --- ResearchAndMarkets.com"[3].
4. PatSnap Synapse: "Donepezil Hydrochloride/Memantine Hydrochloride - Drug Targets and Clinical Trials"[4].
5. FDA: "206439Orig1s000PharmR.pdf - NDA 206-439 (Namzaric; memantine HCl ER and donepezil HCl)"[5].