Exosome Evidence Index

Conditions / Immune system, eyes, and brain

Exosomes for alzheimer's disease

One open-label study with no placebo group. No adverse events; cognitive scores were compared only with each patient’s starting point.

No exosome product is FDA-approved for this or any other condition.

1 study, strongest design first

How to read the bars and marks

Bars: how strong the study design is

More filled bars means a design that can tell more reliably whether the treatment caused the result.

  • Single case or case seriesOne patient or a handful, described without a comparison. It can raise an idea; it cannot show that a treatment works.
  • Study without a control groupA group was treated and followed, but nobody was left untreated for comparison. Improvement may come from time, other care, or the placebo effect.
  • Controlled trialTreated patients were compared with a control: placebo, another treatment, or the untreated side of the face. Most exosome trials at this level are small and short.
  • Phase 3 resultsA large trial designed to prove a treatment works, the kind regulators usually require. No exosome product has published phase 3 results.
  • FDA approvedThe FDA has reviewed the evidence and approved the product for that use. No exosome product is approved for any use.

Marks: what the study found

A solid mark means a benefit over the comparison. Hollow or partly filled marks mean less.

  • Better than controlThe treated group did better than the comparison group on the main measures.
  • Mixed or short-lived resultSome benefit, but only on some measures, in a subgroup, or for a short time.
  • Similar to comparison treatmentAbout the same as another treatment, such as PRP, which may itself be unproven.
  • No benefit over controlThe treated group did no better than placebo or the comparison.
  • Improvement reported, no control groupPatients improved, but without a comparison group there is no way to tell whether the treatment caused it.
  • Safety onlyThe study looked for harms. It was not designed to show whether the treatment works.
  • Stopped for a safety eventThe study was halted after a serious problem in a participant.

More on how studies are graded

  1. Improvement reported, no control groupStrength of design, level 2 of 5: Study without a control group

    Adipose stem cell exosome nasal drops for mild to moderate Alzheimer's disease

    Phase I/II trial, General Psychiatry, 2023 (NCT04388982). 9 planned in the registry. Made from: fat (adipose) stem cells.

    No adverse events. In the medium-dose group, cognitive test scores improved compared with baseline at 12 weeks. Amyloid and tau deposits did not differ between dose groups.