FDA record · Alzheimer's disease
What FDA's own documents say about Aduhelm: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“ADUHELM is indicated for the treatment of Alzheimer's disease.”
Prescribing information, supplement 011 · PDF p. 2 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| EMERGE | NCT02484547 | 3 | 1,455 | 13 of 24 |
| ENGAGE | NCT02477800 | 3 | 1,091 | 13 of 24 |
| PRIME | not given | 1b | 451 | 7 of 24 |
| EMBARK | not given | 3b | 26 | 3 of 24 |
| Study 102 | not given | 21 | 1 of 24 | |
| Study 104 | not given | 16 | 4 of 24 | |
| Study 101 | not given | 8 | 2 of 24 | |
| EVOLVE | not given | 2 | 7 | 3 of 24 |
Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.
Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.
NPI-10
“The adjusted mean change from baseline in NPI-10 at Week 78 compared to placebo was 0.1 (8%, p = 0.9071) for aducanumab high dose and -1.0 (-83%, nominal p=0.0460) for aducanumab low dose.”
Clinical (Medical) Review · PDF p. 75 · fda.gov ↗
8%p = 0.9071-83%p=0.0460
EMERGE · CDR-SB1
“Study 302 demonstrated a statistically significant treatment benefit (smaller increase in CDR-SB1) for aducanumab 10 mg/kg, compared to placebo (-0.39 [-22%], p = 0.0120).”
Summary Review · PDF p. 3 · fda.gov ↗
-22%p = 0.0120
CDR-SB
“The primary endpoint, evaluating the high dose, was statistically significant with a CDR-SB change from baseline relative to placebo of -0.39 (p=0.0120); the low dose had a nonstatistically significant numerical reduction (p = 0.0901).”
Office Director Memorandum · PDF p. 6 · fda.gov ↗
p=0.0120p = 0.0901
CDR-SB
“The primary efficacy endpoint analysis, change from baseline in CDR-SB at Week 78, did not show a difference in the aducanumab high-dose treatment arm compared to placebo (0.03 [2%], p = 0.8330).”
Summary Review · PDF p. 32 · fda.gov ↗
2%p = 0.8330
ADAS-Cog 13
“Statistically significant effects on ADAS-Cog 13 (-1.400, p=0.0097) and ADCS-ADL-MCI (1.7,”
Clinical (Medical) Review · PDF p. 13 · fda.gov ↗
p=0.0097
MMSE
“In fact, there is a statistically significant interaction for the first key secondary endpoint MMSE between APOE and treatment groups, p=0.0096, i.e., the treatment effect(s) is not the same, a nominally significant difference, across APOE subgroups.”
Statistical Review · PDF p. 46 · fda.gov ↗
p=0.0096
ENGAGE · CDRSB
“For the high dose in study 301 correlation between Week 78 CDRSB change and Week 78 ptau change was much smaller and did not reach nominal significance (n=18, Pearson=0.277 p=0.2999 ; Spearman=0.380 p=0.1463).”
Statistical Review · PDF p. 59 · fda.gov ↗
p=0.2999p=0.1463
MMSE
“Dose-related numerical reductions relative to placebo for CDR-SB and MMSE were observed that were nominally significant in the 10 mg/kg dose group (p=0.0464 and 0.0356, respectively).”
Office Director Memorandum · PDF p. 6 · fda.gov ↗
p=0.0464
“Most common adverse reactions (at least 10% and higher incidence compared to placebo): ARIA-Edema, headache, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and fall.”
Prescribing information, supplement 011 · PDF p. 1 · fda.gov ↗
“After an initial titration, the recommended dosage of ADUHELM is 10 mg/kg (see Table 1).”
Prescribing information, supplement 011 · PDF p. 3 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval761178s000lbl.pdf | June 7, 2021 | 22 | dedefdc49d6d | |
| Approval letter761178Orig1s000ltr.pdf | June 7, 2021 | 9 | 2a3948b9b58a | |
| Administrative Correspondence761178Orig1s000AdminCorres.pdf | June 22, 2021 | 98 | archived copy | 678bc11bfc36 |
| Approval Letter761178Orig1s000Approv.pdf | June 22, 2021 | 12 | 0e858c469040 | |
| Chemistry Review761178Orig1s000ChemR.pdf | June 22, 2021 | 47 | archived copy | adbe6959251f |
| Prescribing Information (Label)761178Orig1s000Lbl.pdf | June 22, 2021 | 24 | b3e7a6ef236d | |
| Clinical (Medical) Review761178Orig1s000MedR.pdf | June 22, 2021 | 392 | 4a457dcbec58 | |
| Proprietary Name Review761178Orig1s000NameR.pdf | June 22, 2021 | 25 | archived copy | e4f32b54b02e |
| Office Director Memorandum761178Orig1s000ODMemo.pdf | June 22, 2021 | 15 | 294669838bea | |
| Officer/Employee List761178Orig1s000OEList.pdf | June 22, 2021 | 3 | archived copy | 128d41a35942 |
| Other Reviews761178Orig1s000OtherR.pdf | June 22, 2021 | 66 | archived copy | c51ffde3c613 |
| Pharmacology/Toxicology Review761178Orig1s000PharmR.pdf | June 22, 2021 | 50 | archived copy | 209d42bccb4a |
| Risk Assessment / REMS Review761178Orig1s000RiskR.pdf | June 22, 2021 | 24 | 8b5df7bcb116 | |
| Statistical Review761178Orig1s000StatR.pdf | June 22, 2021 | 113 | 0aa0829e3ad0 | |
| Summary Review761178Orig1s000SumR.pdf | June 22, 2021 | 70 | 236a7a9d873a | |
| Prescribing information, supplement 003761178s003lbl.pdf | July 8, 2021 | 22 | 7378d2639dfc | |
| Approval letter, supplement 003761178Orig1s003ltr.pdf | July 8, 2021 | 4 | cd3b8eeea15c | |
| Prescribing information, supplement 005761178s005lbl.pdf | May 2, 2022 | 25 | 50b778234c12 | |
| Approval letter, supplement 005761178Orig1s005ltr.pdf | May 3, 2022 | 4 | 003f810c816b | |
| Prescribing information, supplement 007761178s007lbl.pdf | February 9, 2023 | 26 | 429f8903af5d | |
| Approval letter, supplement 007 (corrected)761178Orig1s007correctedltr.pdf | February 9, 2023 | 4 | 27ab5fcb737b | |
| Approval letter, supplement 011761178Orig1s011ltr.pdf | August 31, 2023 | 4 | 1dffe318872b | |
| Prescribing information, supplement 011761178s011lbl.pdf | September 1, 2023 | 27 | 627bc5f89f90 | |
| Approval letter, supplement 012761178Orig1s012ltr.pdf | July 2, 2024 | 4 | 91aa8e860039 |
Checked against FDA's copies on September 29, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (curated): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.