The Critical Difference: NIH Research vs. FDA Approval
When discussing medications for any disease in the United States, it's crucial to understand the distinct roles of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The question, "What are the NIH medications for Alzheimer's?" touches on a common point of confusion. The NIH is the nation's premier medical research agency; it conducts and funds extensive research—including foundational studies that lead to drug development [1.3.3, 1.8.2]. However, the NIH does not approve medications for public use. That role belongs exclusively to the FDA, which evaluates the safety and effectiveness of new treatments before they can be prescribed by doctors [1.3.1]. Therefore, all medications available to patients are, more accurately, "FDA-approved," though many originated from NIH-supported science.
FDA-Approved Medications for Alzheimer's Symptoms
For many years, the primary treatments for Alzheimer's have focused on managing cognitive and behavioral symptoms. These drugs do not stop or reverse the underlying disease process but can help improve quality of life for a limited time by supporting communication between nerve cells [1.4.5].
Cholinesterase Inhibitors
This class of drugs works by preventing the breakdown of acetylcholine, a neurotransmitter crucial for memory and thinking [1.4.5]. They are typically prescribed for mild to moderate Alzheimer's.
- Donepezil (Aricept®): Approved for all stages of Alzheimer's [1.4.5, 1.9.1].
- Rivastigmine (Exelon®): Approved for mild to moderate stages, also available as a skin patch [1.4.5, 1.9.1].
- Galantamine (Razadyne®): Approved for mild to moderate stages [1.4.5, 1.9.1].
NMDA Receptor Antagonists
This type of medication works by regulating glutamate, another neurotransmitter involved in brain function. Excess glutamate can lead to brain cell damage [1.8.1].
- Memantine (Namenda®): Approved for moderate to severe Alzheimer's, it can be used alone or in combination with a cholinesterase inhibitor [1.5.1, 1.9.5]. A combination pill of Memantine and Donepezil (Namzaric®) is also available [1.4.5].
Disease-Modifying Therapies: A New Era
A recent and significant breakthrough in Alzheimer's treatment is the development of drugs that target the underlying pathology of the disease—specifically, the buildup of amyloid-beta plaques in the brain [1.8.2]. These are the first therapies shown to change the course of the disease, rather than just manage symptoms [1.9.1].
Anti-Amyloid Antibodies
These medications are monoclonal antibodies administered via intravenous (IV) infusion. They are approved for individuals in the early stages of Alzheimer's—mild cognitive impairment or mild dementia—with confirmed amyloid plaques [1.6.5, 1.9.1].
- Lecanemab (Leqembi®): Granted full FDA approval in 2023, lecanemab was shown to reduce cognitive and functional decline by removing amyloid from the brain [1.2.4, 1.6.5]. It is administered every two weeks [1.6.5].
- Donanemab (Kisunla™): Approved by the FDA in July 2024, donanemab also targets and clears amyloid plaques [1.2.3, 1.6.5]. It is given as a monthly infusion and offers the possibility of stopping treatment once plaques are cleared [1.2.4].
It is important to note that these treatments carry risks, such as Amyloid-Related Imaging Abnormalities (ARIA), which involves temporary brain swelling or micro-bleeds, and require regular MRI monitoring [1.2.4, 1.9.1].
Comparison of Alzheimer's Medication Classes
| Drug Class | Examples | How It Works | Indicated Stage(s) |
|---|---|---|---|
| Cholinesterase Inhibitors | Donepezil, Rivastigmine, Galantamine | Increases acetylcholine levels to help with cognitive symptoms [1.4.5]. | Mild, Moderate, Severe (Donepezil) [1.9.5]. |
| NMDA Receptor Antagonists | Memantine | Regulates the activity of glutamate to protect brain cells [1.5.5, 1.8.1]. | Moderate to Severe [1.9.5]. |
| Anti-Amyloid Antibodies | Lecanemab, Donanemab | Removes amyloid-beta plaques from the brain to slow disease progression [1.6.5]. | Early Stages (Mild Cognitive Impairment or Mild Dementia) [1.6.5, 1.9.1]. |
The Future: The NIH Research Pipeline
The NIH continues to be at the forefront of Alzheimer's research, funding trials for new therapeutic targets beyond amyloid [1.2.5]. Research is exploring drugs in pill form, treatments targeting the tau protein, and therapies addressing inflammation and other aspects of the disease [1.2.2]. One such drug candidate that emerged from NIH science is buntanetap, which is in late-stage clinical trials [1.2.5]. This ongoing research provides hope for more effective and accessible treatments in the future. Learn more about Alzheimer's treatments from the National Institute on Aging.
Conclusion
While the NIH is the engine of biomedical research, the FDA is the gatekeeper for approved medications. Patients with Alzheimer's now have access to two categories of FDA-approved treatments: established drugs that manage symptoms and newer, groundbreaking therapies that modify the disease itself by targeting amyloid plaques. The decision on which treatment to use must be made in close consultation with a neurologist who can weigh the benefits and risks for each individual patient, especially for the newer antibody therapies that require careful screening and monitoring.
