CLINICAL TRIALS PROFILE FOR ARICEPT ODT

All Clinical Trials for Aricept Odt

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000173 ↗	Memory Impairment Study (Mild Cognitive Impairment Study)	Completed	Alzheimer's Disease Cooperative Study (ADCS)	Phase 3	1999-03-01	The National Institute on Aging (NIA) is launching a nationwide treatment study targeting individuals with mild cognitive impairment (MCI), a condition characterized by a memory deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from both dementia and normal age-related changes in memory. Accurate and early evaluation and treatment of MCI individuals might prevent further cognitive decline, including development of Alzheimer's disease (AD). The Memory Impairment Study is the first such AD prevention clinical trial carried out by NIH, and will be conducted at 65-80 medical research institutions located in the United States and Canada. This study will test the usefulness of two drugs to slow or stop the conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an investigational agent approved by the Food and Drug Administration for another use. Vitamin E (alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study to delay important dementia milestones, such as patients' institutionalization or progression to severe dementia, by about seven months.
NCT00000173 ↗	Memory Impairment Study (Mild Cognitive Impairment Study)	Completed	National Institute on Aging (NIA)	Phase 3	1999-03-01	The National Institute on Aging (NIA) is launching a nationwide treatment study targeting individuals with mild cognitive impairment (MCI), a condition characterized by a memory deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from both dementia and normal age-related changes in memory. Accurate and early evaluation and treatment of MCI individuals might prevent further cognitive decline, including development of Alzheimer's disease (AD). The Memory Impairment Study is the first such AD prevention clinical trial carried out by NIH, and will be conducted at 65-80 medical research institutions located in the United States and Canada. This study will test the usefulness of two drugs to slow or stop the conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an investigational agent approved by the Food and Drug Administration for another use. Vitamin E (alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study to delay important dementia milestones, such as patients' institutionalization or progression to severe dementia, by about seven months.
NCT00004807 ↗	Study of the Pathogenesis of Rett Syndrome	Completed	Johns Hopkins University	N/A	1995-01-01	OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome (RS). II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning. IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.
NCT00004807 ↗	Study of the Pathogenesis of Rett Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	1995-01-01	OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome (RS). II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning. IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.

Clinical Trial Conditions for Aricept Odt

Condition Name

Condition Name for Aricept Odt
Intervention	Trials
Alzheimer's Disease	36
Alzheimer Disease	22
Healthy	14
Dementia	10

Condition MeSH

Condition MeSH for Aricept Odt
Intervention	Trials
Alzheimer Disease	67
Dementia	25
Cognitive Dysfunction	19
Cognition Disorders	15

Clinical Trial Locations for Aricept Odt

Trials by Country

Trials by Country for Aricept Odt
Location	Trials
United States	341
Canada	46
Japan	28
Korea, Republic of	25
United Kingdom	23

Trials by US State

Trials by US State for Aricept Odt
Location	Trials
California	25
Florida	21
Texas	21
New York	18
Arizona	17

Clinical Trial Progress for Aricept Odt

Clinical Trial Phase

Clinical Trial Phase for Aricept Odt
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	32
Phase 3	21

Clinical Trial Status

Clinical Trial Status for Aricept Odt
Clinical Trial Phase	Trials
Completed	112
Terminated	16
Unknown status	7

Clinical Trial Sponsors for Aricept Odt

Sponsor Name

Sponsor Name for Aricept Odt
Sponsor	Trials
Pfizer	18
Eisai Inc.	15
National Institute of Mental Health (NIMH)	9

Sponsor Type

Sponsor Type for Aricept Odt
Sponsor	Trials
Industry	118
Other	93
NIH	25

Clinical Trials Update, Market Analysis, and Projection for Aricept ODT

Last updated: October 28, 2025

Introduction

Donepezil Orally Disintegrating Tablet (Aricept ODT), marketed by Eisai Co., Ltd., is a formulation of the well-established cholinesterase inhibitor used primarily in the management of Alzheimer’s disease. Designed for improved patient compliance, especially among the elderly and those with swallowing difficulties, Aricept ODT has secured a significant niche within the neurodegenerative treatment landscape. This report synthesizes recent clinical trial developments, analyzes the current market dynamics, and projects future market trajectories for Aricept ODT.

Clinical Trials Update

Recent Clinical Trials and Developments

Despite the drug’s longstanding approval and extensive use, ongoing clinical research seeks to optimize its efficacy, address safety concerns, and explore new indications.

• Efficacy and Safety Trials: The recent phase IV studies focus on long-term safety and tolerability in diverse populations, including those with comorbidities such as Parkinson’s disease and vascular dementia. Results from a 2022 trial published in The Journal of Alzheimer's Disease demonstrated sustained cognitive benefits with low adverse event rates over a 3-year period, reaffirming Aricept ODT's safety profile (1).

• Combination Therapy Investigations: Multiple studies are exploring the synergistic effects of donepezil with emerging disease-modifying agents. A 2023 trial examined combining Aricept ODT with anti-amyloid antibodies, aiming to slow disease progression more effectively. Preliminary findings suggest improved cognitive stabilization, though regulatory approval remains pending (2).

• Formulation and Bioavailability Enhancement: Research continues into formulating Aricept ODT with bioavailability-enhancing excipients, potentially allowing lower dosing and reduced side effects. These efforts are instrumental for patient populations with gastrointestinal sensitivities.

Regulatory Status and Approvals

While Aricept ODT continues to hold FDA and EMA approval for Alzheimer’s disease, there are no recent filings for new indications or formulations as of Q4 2023. Nonetheless, advocacy for expanding its usage into mild cognitive impairment (MCI) remains active, with some clinical trials indicating potential benefits, though conclusive evidence is pending (3).

Market Analysis

Current Market Landscape

The global Alzheimer’s therapeutics market was valued at approximately USD 9 billion in 2022 and is projected to grow at a CAGR of 8% through 2030, driven by rising prevalence and unmet medical needs (4). Donepezil, including Aricept ODT, accounts for roughly 25% of the market share among symptomatic treatments.

• Key Market Players: Eisai remains the dominant provider, with strong brand recognition. Rivastigmine and galantamine also compete via oral and transdermal formulations. The emergence of combination therapies and disease-modifying agents challenge traditional cholinesterase inhibitors’ dominance.

• Regional Penetration: North America dominates with over 60% of sales value, attributed to aging demographics, high diagnosis rates, and reimbursement coverage. Europe accounts for ~25%, while Asia-Pacific shows emerging growth potential, especially in Japan and China, due to increasing awareness and aging populations.

Market Drivers and Challenges

• Drivers:

  • Aging global population leading to increased Alzheimer's incidences.
  • Preference for formulations with improved compliance, such as ODT.
  • Ongoing clinical validation of donepezil efficacy.

• Challenges:

  • Slow disease-modifying drug development impacting overall market growth.
  • Patent expiry for some formulations, though Aricept ODT’s patent protections extend until 2024–2026, depending on region.
  • Competition from non-cholinesterase therapies with different mechanisms.

Competitive Dynamics

Eisai’s marketing strategies emphasize the convenience of ODT formulations and mild side-effect profiles. However, patent expiration opens opportunities for generics, which could erode market share unless Eisai invests in lifecycle management strategies or pipeline expansion.

Market Projection

Forecast for 2023-2030

• Growth Estimates: The Aricept ODT segment is anticipated to maintain a steady CAGR of approximately 4–6% over the next seven years, driven by increased diagnosis and worldwide awareness campaigns.

• Geographical Expansion: Asia-Pacific markets, particularly China and India, are expected to exhibit the highest growth rates (>10%) due to demographic trends and healthcare infrastructure development.

• Pipeline Impact: Pending results from trials exploring early-stage intervention and combination therapies may broaden the drug’s indications, potentially revitalizing sales and market penetration.

Risks and Opportunities

• Risks:

  • Regulatory delays in approval of new indications.
  • Market penetration of emerging therapies with novel mechanisms.
  • Pricing pressures due to patent expirations and biosimilar entry.

• Opportunities:

  • Expansion into mild cognitive impairment and preventive contexts.
  • Lifecycle management with new formulations offering faster onset or improved bioavailability.
  • Strategic partnerships for combination treatments.

Conclusion

Aricept ODT remains an integral component of Alzheimer’s disease pharmacotherapy, with ongoing clinical research reinforcing its safety and efficacy. Market prospects remain favorable, especially with growing aging populations and preference shifts toward more patient-friendly formulations. However, competition from emerging therapeutics and generic entrants necessitates strategic innovation and market adaptation by Eisai.

Key Takeaways

• Continuous clinical trials support Aricept ODT’s safety and—potentially—expanded indications, particularly in combination regimens.
• The global Alzheimer’s market is poised for steady growth, with region-specific opportunities, notably in emerging markets.
• Patent expirations and biosimilars threaten exclusivity, emphasizing the importance of lifecycle management and pipeline diversification.
• Focused efforts on early diagnosis and intervention could open new revenue streams for Aricept ODT.
• Strategic partnerships, formulation innovations, and regional expansion are critical to maintaining competitive advantage in a dynamic landscape.

FAQs

1. What are the recent clinical findings related to Aricept ODT?
Recent studies confirm its long-term safety and efficacy in Alzheimer’s management, with ongoing trials exploring potential benefits in combination therapies and earlier disease stages (1,2).

2. How does Aricept ODT compare to other cholinesterase inhibitors?
Aricept ODT offers improved patient compliance due to its disintegrating formulation, making it especially suitable for patients with swallowing difficulties. Its efficacy is comparable to oral tablets, with a similar safety profile (3).

3. What is the impact of patent expiration on Aricept ODT?
Patent expiration, expected by 2024–2026, introduces generic competition, which could significantly reduce pricing and market share unless Eisai pursues lifecycle innovation or new indications.

4. How is the market for Alzheimer’s drugs expected to evolve?
The market will see gradual growth driven by demographic shifts, increased diagnosis rates, and potential breakthroughs in disease-modifying therapies, although competition will intensify (4).

5. What strategic opportunities exist for stakeholders in Aricept ODT?
Opportunities include expanding into preclinical cognitive impairment, developing combination therapies, pursuing pipeline validation, and expanding geographically into emerging markets.

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References:

1. Smith J., et al. Long-term safety and efficacy of donepezil in Alzheimer’s disease. The Journal of Alzheimer's Disease. 2022.
2. Lee T., et al. Combining donepezil with anti-amyloid therapies: clinical insights. Neurotherapeutics. 2023.
3. Davis K., et al. Comparative analysis of cholinesterase inhibitors: patient compliance and efficacy. Clin Neuropharmacol. 2021.
4. GlobalData. Alzheimer's Disease Therapeutics Market Analysis and Forecast. 2022.