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Guidelines and regulatory decisions

TL;DR — Guidance for Alzheimer's disease is split across four document families that do not agree with each other: disease-definition criteria (NIA-AA 2011/2018/2024 versus IWG 2014/2024), diagnostic-evaluation guidelines (DETeCD-ADRD 2025, CCCDTD5 2020, NICE NG97, EFNS 2010), appropriate-use documents for specific tests and drugs (amyloid/tau PET AUC 2013→2025, blood-biomarker AUR 2022 and the 2025 clinical practice guideline, lecanemab and donanemab AURs), and regulatory and reimbursement decisions (FDA, EMA, NICE) that reach different conclusions on the same trials. The most consequential live disagreements are: whether an abnormal Core 1 biomarker alone diagnoses AD in an asymptomatic person (Jack 2024, PMID 38934362 says yes; Dubois 2024, PMID 39483064 says call them at risk); whether blood biomarkers can substitute for CSF or PET (Hansson 2022, PMID 35908251 said not yet; Palmqvist 2025, PMID 40729527 says yes if a test achieves ≥90% sensitivity and ≥90% specificity); and whether anti-amyloid antibodies should be used at all — the FDA has approved both drugs and expanded lecanemab delivery options, the EMA has authorised both only for ApoE ε4 non-carriers and heterozygotes, while NICE's appraisals remain in development and its latest draft recommendations are negative. The document-level catalogue with supersession chains lives in literature/guidelines/REGISTRY.md; this page synthesises what they recommend and where they conflict.

1. Defining the disease

Document Position Consequence
NINCDS-ADRDA 1984 (McKhann, PMID 6610841) Clinical diagnosis by exclusion; "the diagnosis cannot be determined by laboratory tests" Probable/possible/definite AD; definite requires histopathology
NIA-AA 2011 (PMID 21514247; 21514250; 21514249; 21514248) Three clinical stages; biomarkers modify certainty; preclinical criteria explicitly research-only Firewall between research and practice
NIA-AA 2018 research framework (PMID 29653606) AT(N) biomarker classification; disease defined biologically; "premature and inappropriate" in general practice Common research vocabulary
Alzheimer's Association 2024 revised criteria (PMID 38934362) Biological process beginning with asymptomatic ADNPC; abnormal Core 1 biomarker sufficient to diagnose; Core 2 prognostic Removes the firewall
IWG-2 2014 (PMID 24849862) and IWG 2024 (PMID 39483064) Clinical phenotype plus biomarker; amyloid-positive cognitively normal people are at risk, not diseased Retains a clinical requirement

Detail and the underlying progression data on diagnostic criteria and the biological definition.

2. Evaluating a patient

DETeCD-ADRD (2025) is the first US diagnostic-evaluation guideline in two decades and the first written for primary care as well as specialists. Developed by modified Delphi from 7,374 publications screened to 133 included, it structures evaluation as steps aimed at characterising and disclosing the patient's cognitive-functional status, cognitive-behavioural syndrome and likely underlying brain disease, so that a care plan can be built for the patient–care-partner dyad. Its own stated condition is notable: outcomes should improve "if clinicians use this guideline and health-care systems provide adequate resources" (Atri 2025, PMID 39713942; Dickerson 2025, PMID 39713957), with a companion paper on validated assessment instruments (PMID 39713939).

CCCDTD5 (2020) covered eight topics including the clinical utility of the NIA-AA research framework, vascular cognitive impairment criteria, case finding, neuroimaging and fluid biomarkers, non-cognitive markers, risk reduction, psychosocial interventions and deprescribing (Ismail 2020, PMID 32725777). Its imaging subgroup moved MRI to a more central role, added visual rating scales for atrophy and white-matter change, favoured FDG-PET decisively over SPECT, clarified the role of amyloid PET, and added DaTscan for separating AD from Lewy body disease (Brisson 2020, PMID 33532543).

AAN MCI guideline (2018) — now marked retired in PubMed — set MCI prevalence at 6.7% (ages 60–64) rising to 25.2% (80–84), with cumulative 2-year dementia incidence of 14.9% in people over 65 with MCI. Its recommendations: assess with validated tools (Level B); evaluate modifiable risk factors, functional impairment and behavioural symptoms (Level B); monitor over time (Level B); discontinue cognitively impairing medications (Level B); clinicians may choose not to offer cholinesterase inhibitors (Level B), and if offering must first discuss the lack of evidence (Level A); recommend regular exercise (Level B); may recommend cognitive training (Level C) (Petersen 2018, PMID 29282327).

EFNS 2010 covered clinical diagnosis, blood tests, neuropsychology, neuroimaging, EEG, CSF, genetic testing, disclosure, treatment, behavioural symptoms, legal issues and caregiver support, with graded recommendations (Hort 2010, PMID 20831773) and a companion neuroimaging task-force document (Filippi 2012, PMID 22900895). It is the oldest document in current use in this family and predates every biomarker development described on fluid biomarkers.

NICE NG97 (England) covers diagnosis and management of dementia including AD, published 20 June 2018, reviewed 24 October 2025 with a decision not to update the recommendations; minor amendments were made in April and June 2025 (NICE — "Dementia: assessment, management and support for people living with dementia and their carers", https://www.nice.org.uk/guidance/ng97, directly fetched 2026-08-31).

3. Appropriate use of tests

Amyloid and tau PET

Document Content
Johnson 2013 (PMID 23359661; PMID 23360977) First amyloid-PET AUC: appropriate only with objective cognitive impairment, AD as a diagnostic consideration and genuine aetiologic uncertainty; explicit list of inappropriate uses; the task force noted no empirical evidence of impact on clinical outcomes was yet available
Rabinovici 2025 (PMID 39776249; PMID 39778970) 17 clinical scenarios rated by modified Delphi. Amyloid PET: 7 appropriate, 2 uncertain, 8 rarely appropriate. Tau PET: 5 appropriate, 6 uncertain, 6 rarely appropriate. Rated separately as stand-alone modalities

The larger "uncertain" fraction for tau PET is an accurate representation of a modality whose autopsy validation showed high sensitivity but reader-variable specificity (52–92%) — see imaging and neuropathology.

Blood biomarkers — a guideline reversal in three years

Document Recommendation
Hansson 2022, Appropriate Use Recommendations (PMID 35908251) Use as (pre-)screeners for trial enrolment with PET/CSF confirmation; study longitudinal change within trials; not as primary endpoints in pivotal trials; cautious use in specialised memory clinics with confirmation wherever possible; more data needed before stand-alone diagnostic use or any primary-care use
Palmqvist 2025, Alzheimer's Association Clinical Practice Guideline (PMID 40729527) GRADE-based, brand-agnostic, performance-based: a blood test with ≥90% sensitivity and ≥75% specificity may be used as a triaging test; a test with ≥90% sensitivity and ≥90% specificity may substitute for amyloid PET or CSF in cognitively impaired patients in specialised care. Cautions that diagnostic accuracy varies substantially and that many commercially available tests do not meet these thresholds, especially with a single cutoff; not a substitute for clinical evaluation; use only with careful consideration of pre-test probability
Spanish Society of Neurology 2025 positioning document (PMID 40685136) Use in specialised units with clinical-context interpretation and continuing research; more data required for general neurology and primary care; not recommended for asymptomatic screening or direct-to-consumer testing

The 2025 guideline is scoped to specialised care and to people with objective cognitive impairment. It does not endorse primary-care or asymptomatic use, despite prospective primary-care accuracy data existing (Palmqvist 2024, PMID 39068545). The performance thresholds are the operative content: they convert "should I trust a blood test?" into "does this specific assay, at this cutoff, meet 90/90?" — a question most marketed tests currently answer no to.

4. Appropriate use of anti-amyloid antibodies

Element Lecanemab AUR (Cummings 2023, PMID 37357276) Donanemab AUR (Rabinovici 2025, PMID 40155270)
Candidates MCI due to AD or mild AD dementia, confirmed amyloid pathology MCI or mild dementia due to AD, Clinical Stages 3–4, MMSE 20–30, PET or CSF confirmation; tau PET not required
APOE Genotyping recommended to inform risk discussion Genotyping should be performed before treatment
MRI Baseline required; institutional preparedness and protocols for serious events mandatory Within 12 months of starting; exclude if >4 cerebral microbleeds, cortical superficial siderosis, or major vascular contribution to cognitive impairment; surveillance before the 2nd, 3rd, 4th and 7th infusions, before the 12th dose in higher-risk patients, and whenever ARIA is suspected
Anticoagulation Patients requiring anticoagulants should not receive lecanemab until more data are available —
Stopping — May consider stopping when amyloid clearance is demonstrated on PET, typically 12–18 months after starting
Framing Communication and trust-building are foundational; culture-specific communication emphasised Shared decision-making grounded in the patient's values and goals of care

Both documents deliberately mirror trial eligibility because "safety and efficacy of lecanemab are known only for patients like those participating in the phase 2 and phase 3 lecanemab trials" (PMID 37357276). Applied to a real memory-clinic population, they admitted about a quarter of amyloid-positive patients (Jeon 2025, PMID 41225766) — see anti-amyloid immunotherapy.

5. Regulators and payers disagree on the same evidence

Body Decision Terms
FDA (US) Lecanemab: accelerated approval January 2023, converted to traditional approval July 2023. Donanemab (Kisunla): approved 2 July 2024. A subcutaneous lecanemab maintenance regimen was approved in 2025 and an at-home subcutaneous starting regimen on 13 July 2026 Treatment is initiated in MCI or mild dementia. Labelling warns that ARIA risk is increased in ApoE4 homozygotes, recommends ApoE ε4 testing before starting, and cautions on anticoagulants and other intracerebral-haemorrhage risk factors. The 2026 delivery approval changes where starting doses can be given, not the need for diagnostic confirmation and safety monitoring (FDA approval notices and prescribing information, including https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-home-starting-dose-alzheimers-disease-treatment, directly fetched 2026-08-31)
EMA (EU) Leqembi authorised 15 April 2025 after re-examination; Kisunla authorised 24 September 2025 Both are restricted to adults with MCI or mild dementia due to AD who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology (EMA — "Leqembi", https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi; "Kisunla", https://www.ema.europa.eu/en/medicines/human/EPAR/kisunla; directly fetched 2026-08-31)
NICE (England) Both technology appraisals are in development, with expected publication listed as TBC on 31 August 2026; the latest draft recommendations remain negative Donanemab's appeal was upheld in part and a new draft consultation ran in March 2026; lecanemab underwent a second draft consultation in March 2026 and a third committee meeting on 8 July 2026. These are not final published recommendations (NICE appraisal pages, https://www.nice.org.uk/guidance/indevelopment/gid-ta11220 and https://www.nice.org.uk/guidance/indevelopment/gid-ta11221/documents, directly fetched 2026-08-31)

The EMA's initial lecanemab rejection was read at the time as reflecting concern about clinical value and manageability, and the divergence between MHRA licensing and NICE's draft cost-effectiveness rejection was flagged as fuelling the debate on feasibility (Martorana 2025, PMID 39487946). The FDA and EMA have both authorised the two antibodies, but the EMA excludes ApoE ε4 homozygotes; NICE has continued to recommend against NHS use in draft documents while its appraisals remain unfinished. The underlying trial data are the same, but the authorities apply different safety, clinical-value and affordability thresholds.

6. Prevention guidance

WHO issued Risk reduction of cognitive decline and dementia: WHO guidelines in 2019, structured around lifestyle and behaviour interventions, interventions for physical health conditions, and specific interventions, developed through a formal guideline-development methodology as part of Action Area 3 of the Global Action Plan on the Public Health Response to Dementia 2017–2025 (WHO — "Risk reduction of cognitive decline and dementia: WHO guidelines", https://www.who.int/publications/i/item/9789241550543, accessed 2026-08-31; summarised in Chowdhary 2021, PMID 35082745). CCCDTD5 also addressed risk reduction and prevention within its remit (PMID 32725777).

The gap between this guidance and the randomised evidence is discussed on risk reduction and prevention: recommendations rest largely on observational associations, while multidomain trials have produced very small cognitive effects and no demonstrated reduction in dementia incidence.

7. Treatment and deprescribing

Symptomatic-drug recommendations differ mainly in tone. The AAN's MCI guideline says clinicians may choose not to offer cholinesterase inhibitors and must disclose the lack of evidence if they do (PMID 29282327). CCCDTD5's deprescribing subcommittee recommends that cognitive enhancers be discontinued where there is no ongoing evidence of benefit or where the original indication was inappropriate (e.g. MCI), that deprescribing occur gradually with reinitiation if cognition or function deteriorates, that treatment be continued where neuropsychiatric symptoms improved on it, and that deprescribing be deferred until significant neuropsychiatric symptoms have stabilised (Herrmann 2022, PMID 35128025). Those recommendations are consistent with the DOMINO-AD withdrawal data on symptomatic and supportive therapy.

The American Psychiatric Association issued a dedicated practice guideline on antipsychotics for agitation or psychosis in patients with dementia (Reus 2016, PMID 27133416). That document sits alongside the Cochrane finding that atypical antipsychotics reduce agitation only slightly (SMD −0.21) with a negligible effect on psychosis (SMD −0.11) and increased somnolence, extrapyramidal symptoms and serious adverse events (Mühlbauer 2021, PMID 34918337) — quantified on neuropsychiatric symptoms. The guideline's existence, rather than any class/level table in its PubMed record (the 2016 summary has no abstract), is the cataloguing fact: the largest US psychiatric body has a current, symptom-specific document in a field whose diagnostic and DMT documents have multiplied while its antipsychotic document has not been superseded.

Where the documents conflict

# Conflict Sides
1 Does a Core 1 biomarker diagnose AD in an asymptomatic person? AA 2024 yes (PMID 38934362) vs IWG 2024 no, "at risk" (PMID 39483064)
2 Can blood biomarkers replace CSF/PET? AUR 2022 no (PMID 35908251) vs CPG 2025 yes if ≥90%/≥90% in specialised care (PMID 40729527)
3 Should anti-amyloid antibodies be used? FDA approval vs EMA genotype-restricted authorisation vs NICE draft non-recommendation in appraisals still under development
4 Is APOE genotyping optional or required before treatment? Lecanemab AUR "recommended to inform risk discussion" vs donanemab AUR "should be performed" (PMID 37357276; PMID 40155270)
5 Is anticoagulation a contraindication? Lecanemab AUR advises against treatment; FDA labelling advises caution; donanemab AUR is silent
6 Are cholinesterase inhibitors worth offering in MCI? AAN: may decline to offer, must disclose lack of evidence; CCCDTD5: deprescribe if indication was MCI (PMID 29282327; PMID 35128025)
7 Is tau PET clinically useful? 6 of 17 scenarios "uncertain" in the 2025 AUC — the largest uncertainty block in any current document (PMID 39776249)

Recommendation strength beside effect size

Two additional GRADE documents make the symptomatic-treatment disagreement more legible. The 2015 EFNS-ENS/EAN combination guideline pooled four trials (1,549 people): ChEI plus memantine versus ChEI alone improved global impression by SMD −0.20 (95% CI −0.31 to −0.09), cognition −0.27 (−0.37 to −0.17) and behaviour −0.19 (−0.31 to −0.07). Evidence quality was high for behaviour, moderate for cognition/global impression and low for activities of daily living, so the panel issued only a weak recommendation for combination therapy (Schmidt 2015, PMID 25808982). By contrast, the Korean Dementia Association 2025 guideline gives a strong recommendation based on moderate evidence for cholinesterase inhibitors in AD and a strong recommendation for memantine in moderate-to-severe AD (Kim 2025, PMID 39944527).

For behavioural symptoms, the companion Korean guideline recommends antipsychotics such as risperidone for aggression and psychosis conditionally, and advises citalopram for agitation in AD, with medication choice tied to severity and safety; the record does not state a strength grade for the citalopram advice (Byeon 2025, PMID 39944528). The guideline stance is therefore not “antipsychotics work” but “conditional use despite limited benefit and material harm.” This is compatible with the Cochrane SMD of −0.21 for agitation and increased serious adverse events, not a contradiction of it (Mühlbauer 2021, PMID 34918337).

For blood biomarkers, the guideline threshold rests on heterogeneous evidence: 49 studies of 31 tests yielded sensitivity 49.3–91.4%, specificity 61.5–96.7%, and GRADE certainty from moderate to very low (Pahlke 2025, PMID 41193403). Thus the ≥90%/≥90% substitute rule is a performance gate, not a statement that the evidence for every marketed assay is high certainty.

Open questions

  • Will the 2024 criteria and the IWG position converge, or will two definitions of the same disease persist in parallel literatures (PMID 38934362; PMID 39483064)?
  • Which commercially available blood biomarker assays actually meet the 90%/90% threshold in independent evaluation, and who audits that (Palmqvist 2025, PMID 40729527)?
  • What final recommendations will NICE publish after the donanemab appeal and the 2026 reconsultations, and what evidence would change the draft cost-effectiveness conclusions (NICE appraisal pages; Martorana 2025, PMID 39487946)?
  • Is the EMA's ε4-homozygote exclusion supported by outcome data, or only by the ARIA gradient (EMA Leqembi authorisation; Qi 2026, PMID 41478817)?
  • Does DETeCD-ADRD's conditional — that health systems provide adequate resources — hold anywhere, and what happens to outcomes where it does not (Atri 2025, PMID 39713942)?
  • Should the 2010 EFNS guideline be formally retired given that it predates plasma biomarkers, tau PET and disease-modifying therapy (Hort 2010, PMID 20831773)?

References

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Non-journal sources. NICE — NG97, https://www.nice.org.uk/guidance/ng97; lecanemab appraisal, https://www.nice.org.uk/guidance/indevelopment/gid-ta11220; donanemab appraisal documents, https://www.nice.org.uk/guidance/indevelopment/gid-ta11221/documents. EMA — "Leqembi", https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi; "Kisunla", https://www.ema.europa.eu/en/medicines/human/EPAR/kisunla. WHO — "Risk reduction of cognitive decline and dementia: WHO guidelines" (2019), https://www.who.int/publications/i/item/9789241550543. FDA — Leqembi prescribing information, https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s001lbl.pdf; "FDA approves first at-home starting dose for Alzheimer's disease treatment", https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-home-starting-dose-alzheimers-disease-treatment. All directly fetched 2026-08-31.