Use of anti-amyloid therapies for Alzheimer’s disease in Brazil: a position paper from the Scientific Department of Cognitive Neurology and Aging of the Brazilian Academy of Neurology

Barbosa, Breno José Alencar Pires; Resende, Elisa de Paula França; Castilhos, Raphael Machado; Borelli, Wyllians Vendramini; Frota, Norberto Anízio Ferreira; Balthazar, Marcio Luiz Figueredo; Amato Filho, Augusto Celso Scarparo; Smid, Jerusa; Barbosa, Maira Tonidandel; Coutinho, Artur Martins; Souza, Leonardo Cruz de; Schilling, Lucas Porcello; Silva, Mari Nilva Maia da; Fernandes, Gustavo Bruniera Peres; Bertolucci, Paulo Henrique Ferreira; Nitrini, Ricardo; Engelhardt, Eliasz; Forlenza, Orestes Vicente; Caramelli, Paulo; Brucki, Sonia Maria Dozzi; Studart Neto, Adalberto

doi:10.1590/1980-5764-DN-2024-C002

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Consensus • Dement. neuropsychol. 18 • 2024 • https://doi.org/10.1590/1980-5764-DN-2024-C002 linkcopy

Use of anti-amyloid therapies for Alzheimer’s disease in Brazil: a position paper from the Scientific Department of Cognitive Neurology and Aging of the Brazilian Academy of Neurology

Uso de terapias antiamiloide para a doença de Alzheimer no Brasil: um posicionamento do Departamento Científico de Neurologia Cognitiva e do Envelhecimento da Academia Brasileira de Neurologia

Authorship SCIMAGO INSTITUTIONS RANKINGS

Novel therapies for Alzheimer’s disease, particularly anti-amyloid drugs like lecanemab and donanemab, have shown modest clinical benefits but also significant risks. The present paper highlights the challenges of access to diagnosis, cost-effectiveness, safety, and the need for more representation of diverse populations in clinical trials. Recommendations include careful patient selection, risk-benefit analysis, and the importance of proven amyloid pathology for treatment. Future work involves further research on anti-amyloid therapies in Brazil and the development of more effective treatments for Alzheimer’s disease.

Keywords:
Alzheimer Disease; Amyloid; Therapeutics; Antibodies, Monoclonal

PET markers	Cerebrospinal fluid markers
[¹¹C]-PIB	Aβ42:Aβ40 ratio
[¹⁸F]-Florbetaben	p-tau181/Aβ42 ratio

	Drug		Donanemab	Lecanemab
	Study name		TRAILBLAZER-ALZ 2	CLARITY-AD
Clinical stage (%)		MCI	17.1	61.5
Clinical stage (%)		Mild dementia	82.9	38.5
Global CDR score (%)*		0.5	60.8	80.8
Global CDR score (%)*		1.0	36.0	19.2
CDR-SB (max. 18) (mean±sd)*			4.0±2.1	3.2±1.3

			Donanemab (TRAILBLAZER-ALZ 2)	Lecanemab (CLARITY-AD)
MCI or mild dementia	MMSE in the sample		20–28	≥22
	CDR		-	Global 0.5 or 1.0 \| Memory ≥0.5
	Other		gradual, progressive memory change for ≥6 months	gradual decline in the past year, corroborated
	AD biomarkers	Amyloid PET	positive scan and	positive scan or
		CSF	-	t-tau/ Aβ⁴²
		Tau PET	positive scan	-
Characteristics	Age		60–85	50–90
	Sex (% female)		53.3	52.0
	Race		White 94.9%	White >75.0%
			Black 2.9%	Black ~2.5%
			Asian 1.1%	Asian 17.0%
	BMI		-	17–35
	AChE-i or memantine		if stable for 30+ days	if stable for 12+ weeks
	Care partner		Yes	yes
Excluded health conditions	cause of cognitive impairment		any non-AD condition	any non-AD condition
	Laboratory tests		elevated liver enzymes	low B12, high TSH
	TIA/stroke		-	past year
	Seizure		recurrent seizures (except childhood febrile seizures)	past year
	Immune/Allergy		significant multiple or severe drug allergies	immunologic disease that is uncontrolled or requires systemic therapy
	Psychiatric		interfering, actively suicidal, or chronic psychosis	interfering, GDS ≥8, suicidal behavior (5 years)
	Cancer		past five years (except those with a low risk of spread)	past three years (except skin/prostate)
	HIV		-	known HIV+
	Substance use		drug use disorder for the past two years	dependence or abuse for the past two years
	Bleeding		-	uncontrolled, e.g. platelets < 50.000 or INR >1.5
MRI exclusions	Microhemorrhage		>4 microhemorrhages	>4 microhemorrhages
	Macrohemorrhage		any macrohemorrhage	any macrohemorrhage (10 mm)
	Siderosis		more than one area of superficial siderosis	any superficial siderosis
	Small vessel disease		severe white matter disease	severe small vessel disease
	Other		any clinically significant finding that would impact safe participation in the study	vasogenic edema, tumefactive lesions, tumor/mass (except small meningioma or cyst), contusion, encephalomalacia, aneurysm, inflammatory amyloid angiopathy

ARIA type	Radiographic severity
ARIA type	Mild	Moderate	Severe
ARIA-E	FLAIR hyperintensity confined to sulcus and/or cortex/subcortex white matter in one location <5 cm	FLAIR hyperintensity 5–10 cm in single greatest dimension, or more than one site of involvement each measuring <10 cm	FLAIR hyperintensity >10 cm with gyral swelling and sulcal effacement. One or more sites may be noted.
ARIA-H microhemorrhages	<4 new incident microhemorrhages	5–9 new incident microhemorrhages	≥10 new incident microhemorrhages
ARIA-H superficial siderosis	One focal area of superficial siderosis	Two focal areas of superficial siderosis	More than two focal areas of superficial siderosis

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Academia Brasileira de Neurologia, Departamento de Neurologia Cognitiva e Envelhecimento R. Vergueiro, 1353 sl.1404 - Ed. Top Towers Offices, Torre Norte, São Paulo, SP, Brazil, CEP 04101-000, Tel.: +55 11 5084-9463 | +55 11 5083-3876 - São Paulo - SP - Brazil
E-mail: revistadementia@abneuro.org.br | demneuropsy@uol.com.br

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[1] Abbreviations: PET, positron emission tomography; Aβ, amyloid beta; p-tau, phosphorylated tau protein.