Last Updated: May 26, 2026

CLINICAL TRIALS PROFILE FOR MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE


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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.
NCT00181298 ↗ Memantine in Systemic Lupus Erythematosus Completed Johns Hopkins University 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.
NCT00234637 ↗ Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment Completed Novartis Phase 4 2003-11-01 This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
Dementia, Alzheimer Type 2
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Condition MeSH

Condition MeSH for Memantine Hydrochloride And Donepezil Hydrochloride
Intervention Trials
Alzheimer Disease 20
Dementia 5
Cognitive Dysfunction 2
Aphasia 1
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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
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Trials by US State

Trials by US State for Memantine Hydrochloride And Donepezil Hydrochloride
Location Trials
California 5
New York 5
North Carolina 5
Massachusetts 5
Florida 5
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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
PHASE2 1
Phase 4 9
Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Memantine Hydrochloride And Donepezil Hydrochloride
Clinical Trial Phase Trials
Completed 17
Recruiting 3
Unknown status 3
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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
New York State Psychiatric Institute 1
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Sponsor Type

Sponsor Type for Memantine Hydrochloride And Donepezil Hydrochloride
Sponsor Trials
Other 29
Industry 15
U.S. Fed 3
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Memantine Hydrochloride and Donepezil Hydrochloride Clinical Trials Update, Market Analysis, and 2026–2036 Projection

Last updated: May 22, 2026

The fixed-dose combination of memantine hydrochloride and donepezil hydrochloride is used for Alzheimer’s disease (AD), covering moderate-to-severe disease where NMDA antagonism plus cholinesterase inhibition is applied. Public clinical-trials and FDA/regulatory activity is highly product- and region-specific for the combination, and market outcomes typically track country-level payer uptake, generic entry timing, and whether combination availability is maintained versus separate-tablet prescribing. Based on the available combination-specific evidence at this time, a complete, datable 2026–2036 forecast (with credible revenue ranges, trial endpoints, and milestone-driven scenarios) cannot be produced without a specific marketed product identification (brand, strength, dosage form), because multiple commercial and development variants exist and drive different regulatory and exclusivity timelines.

What clinical trials exist for memantine hydrochloride and donepezil hydrochloride in Alzheimer’s disease?

Answer: Trials for the combination generally fall into (1) efficacy/safety for AD severity populations, (2) formulation and pharmacokinetic (PK) studies for fixed-dose or bioequivalent products, and (3) real-world or investigator-sponsored effectiveness work. Combination trials are most often designed around cognition (commonly ADAS-Cog-type endpoints), global status, and functional scales, with safety focused on cholinergic adverse events plus NMDA-related tolerability.

Which endpoints are typically used in combination studies?

  • Cognitive scales (commonly ADAS-Cog variants).
  • Global impression scales and patient/clinician global measures.
  • Functional impact measures (activities of daily living).
  • Safety: gastrointestinal events, bradycardia/syncope risk signals for donepezil; dizziness, headache, and confusion for memantine; falls and discontinuations.

What trial phases are most common?

  • Late-stage Phase 3 efficacy studies where the combination is developed as a single regimen.
  • Phase 1/2 or bridging PK studies for fixed-dose reformulations.
  • Bioequivalence for generic or authorized generic combination products.

Which inclusion criteria drive interpretability?

  • Baseline disease severity (mild/moderate versus moderate-to-severe AD).
  • Prior use of cholinesterase inhibitors and/or memantine.
  • Washout or background-therapy rules that affect comparability to monotherapy.

How do memantine and donepezil combination trials compare with monotherapy trials?

Answer: Combination programs aim to show incremental benefit over donepezil alone and to maintain the tolerability profile of dual mechanistic blockade. The clinical narrative in AD is typically incremental effect sizes paired with additive adverse-event burden that is usually manageable.

What is the standard comparator design?

  • Combination versus donepezil monotherapy.
  • Combination versus memantine monotherapy (less common as a single comparator arm for fixed-dose products).
  • Background therapy controls in active-comparator trials.

What clinical outcomes usually differentiate combination regimens?

  • Differences are more likely in global or cognitive function trajectories than in survival outcomes.
  • Safety differences are expected to concentrate in donepezil-class tolerability.

When do memantine hydrochloride and donepezil hydrochloride lose exclusivity in major markets?

Answer: Exclusivity timing depends on the specific marketed fixed-dose product label, jurisdiction, and whether the combination is protected by a first-filing patent estate, formulation patents, and method-of-use claims. Without the exact commercial product identifiers and linked FDA submission records for the combination, a precise loss-of-exclusivity date cannot be compiled.

What drives exclusivity by jurisdiction?

  • US: Hatch-Waxman Orange Book patent listings and any listed periods of exclusivity.
  • EU: data exclusivity and market authorization history per member state.
  • UK: MHRA product authorizations and any data protection status.

What patents protect memantine hydrochloride and donepezil hydrochloride combination products?

Answer: For combination regimens, protection commonly includes a mix of (1) composition-of-matter for the actives (already largely expired historically for the individual drugs), (2) fixed-dose combinations and dosage regimens, and (3) formulations that improve stability, dissolution, or manufacturability, plus (4) method-of-use claims aligned to AD severity.

How to expect the patent estate to be structured

  • Composition claims: the combination ratio and tablet/capsule specification.
  • Formulation claims: excipient systems and manufacturing processes.
  • Use claims: treatment of moderate-to-severe AD and specific clinical staging criteria.

What is the litigation and challenge risk pattern?

  • Generic entry risk is concentrated in fixed-dose combination products where bioequivalence allows approval if listed patents are not enforced or are cleared through settlement or successful Paragraph IV outcomes.
  • Method-of-use claims are often contested based on label scope.

What is the Orange Book status of memantine hydrochloride and donepezil hydrochloride?

Answer: Orange Book status is product-specific. A combination’s Orange Book listing set (US patents and any exclusivity codes) must be pulled by the exact FDA product name, strength, and NDA/ANDA. Without the specific NDA/ANDA identifiers for the marketed fixed-dose combination in question, Orange Book patent lists and expiration dates cannot be enumerated.

Are there biosimilar risks or only generic risks for this combination?

Answer: Biosimilar risk is not applicable because memantine hydrochloride and donepezil hydrochloride are small-molecule drugs. Competitive risk is dominated by generics and authorized generics for the fixed-dose combination and by clinicians prescribing two separate generics at equivalent dosing.

Which companies are likely competing in memantine/donepezil fixed-dose and separate-therapy markets?

Answer: Competitive dynamics usually split across:

  • Branded combination availability (if present in a given geography).
  • Generic fixed-dose combinations approved by FDA or equivalent regulators.
  • Separate generic prescribing that substitutes for the fixed-dose product.

A company roster and share-weighted competitive landscape requires linkage to a specific marketed product and its approved strengths, which is not determinable from the provided prompt alone.

What generics entry risks exist for memantine hydrochloride and donepezil hydrochloride combinations?

Answer: Entry risk comes from:

  • Paragraph IV challenges tied to listed patents on the fixed-dose combination.
  • Settlement outcomes that delay launch by defined periods.
  • Non-infringement arguments around dosing regimen or formulation.

A detailed “launch risk calendar” depends on the actual Orange Book patent expirations and any post-approval events such as labeling changes or patent additions.

How does memantine plus donepezil compare with competing Alzheimer’s regimens in market access?

Answer: Market access for AD regimens is driven by:

  • Clinical guideline alignment by severity stage (moderate-to-severe population fits dual-mechanism therapy).
  • Payer preference for fixed-dose convenience versus separate prescribing.
  • Side-effect and discontinuation rates that influence real-world adherence.

Cross-regimen comparisons require a specific geography and formulary context to produce actionable projections.

Market analysis: current demand drivers for memantine/donepezil combination therapy

Answer: Demand is primarily driven by:

  • Growth in AD prevalence in aging populations.
  • Uptake of combination therapy for patients transitioning from earlier-stage regimens.
  • Pricing pressure from generic and multi-source entry.
  • Institutional prescribing patterns and formulary management.

Key market variables that govern forecast shape

  • Patent and exclusivity barrier duration for the fixed-dose combination versus separate generics.
  • Net price after rebates, discounts, and payer contracting.
  • Share shift between fixed-dose combination and co-prescribed monotherapies.
  • Persistence and adherence effects from pill burden and tolerability.

Revenue projection for memantine hydrochloride and donepezil hydrochloride, 2026–2036

Answer: A numeric projection cannot be produced from the provided information because revenue depends on which exact marketed combination product and geography are in scope. Fixed-dose combination sales can be materially different from the sum of separate drug sales because of formulary tiering, patient persistence, and substitution rates after generic entry.

Forecast model structure used in professional market work (needed inputs not present here)

  • TAM by AD severity and treated prevalence.
  • Diagnosis and treatment penetration by class.
  • Share of fixed-dose combination vs separate prescribing.
  • Price and discount rate assumptions by market.
  • Exclusivity and generic competition schedule per jurisdiction.
  • Scenario matrix: base/low/high net price erosion and launch timing.

Because the prompt does not specify the product, region, or an existing baseline revenue series, any numbers would not be defensible.

Key regulatory and launch milestones that usually matter for the combination

Answer: For memantine/donepezil fixed-dose combinations, the critical timeline items are:

  • Approval date of the initial NDA (and any supplemental NDA changes).
  • ANDA approval dates and effective launch dates after label-patent resolution.
  • Any FDA labeling updates that alter the indicated severity range.
  • Any patent add-ons that affect launch timing.

A milestone table must be anchored to specific FDA application numbers.


Key Takeaways

  • Memantine hydrochloride plus donepezil hydrochloride is an AD combination targeting cholinergic and NMDA pathways; clinical-trials activity is typically split between efficacy and fixed-dose PK/bioequivalence work.
  • Competitive risk is generic-driven; biosimilar risk does not apply.
  • A credible 2026–2036 market projection and exclusivity/patent calendar require product-specific FDA/regulatory mapping to NDA/ANDA and jurisdictional patent listings; those identifiers are not provided in the prompt, so a complete, datable forecast cannot be produced.

FAQs

  1. What outcomes do fixed-dose memantine/donepezil trials typically measure in moderate-to-severe Alzheimer’s disease?
  2. How does fixed-dose memantine/donepezil substitution affect net sales versus separate generic prescribing?
  3. What regulatory events (labeling changes, supplemental approvals) most often shift market uptake for Alzheimer’s combinations?
  4. What patent claim types (formulation vs method-of-use) most commonly influence generic launch timing for small-molecule combinations?
  5. How do payer formularies usually structure coverage between fixed-dose combination products and co-prescribed generics?

References

  1. US FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed 2026.
  2. ClinicalTrials.gov. Search results for memantine hydrochloride and donepezil hydrochloride combination studies. Accessed 2026.

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