NeuroEPO plus (NeuralCIM®) in mild-to-moderate Alzheimer’s clinical syndrome: the ATHENEA randomized clinical trial

Sosa, Saily; Bringas, Giosmany; Urrutia, Nelky; Peñalver, Ana Ivis; López, Danay; González, Evelio; Fernández, Ana; Hernández, Zenaida Milagros; Viña, Ariel; Peña, Yamile; Batista, Juan Felipe; Valenzuela, Carmen; León, Kalet; Crombet, Tania; Rodríguez, Teresita; Pérez, Leslie

doi:10.1186/s13195-023-01356-w

Alzheimer's Research & Therapy

Table 2 Clinical outcomes from baseline to 48 weeks

From: NeuroEPO plus (NeuralCIM^®) in mild-to-moderate Alzheimer’s clinical syndrome: the ATHENEA randomized clinical trial

Outcomes	NeuroEPO plus 0.5 mg	NeuroEPO plus 1.0 mg	Placebo
Primary efficacy outcome
Change from baseline to 48 weeks in the ADAS-Cog11 score
No. of participants evaluated^a	57	56	57
Adjusted median change	−3.0	−4.0	4.0
Adjusted absolute median difference vs. placebo (95% CI)	7.0 (4.5 to 9.5)	8.0 (5.2 to 10.8)
P value vs. placebo	0.000	0.000
Secondary efficacy outcomes
Change from baseline to 48 weeks in the CIBIC+ score
No. of participants evaluated^a	57	56	57
Median change	−1.0	−1.0	2.0
Absolute median difference vs. placebo (95% CI)	3.0 (2.2 to 3.7)	3.0 (2.0 to 3.9)
P value vs. placebo	0.000	0.000
Change — no. (%)
Improvement	40 (70.2)	39 (69.6)	0
No change	13 (22.8)	8 (14.3)	1 (1.8)
Worsening	4 (7.0)	9 (16.1)	56 (98.2)
Change from baseline to 48 weeks in the GDS score
No. of participants evaluated^b	50	49	49
Change — no. (%)
No increase	45 (90.0)	47 (95.9)	34 (69.4)
Increase	5 (10.0)	2 (4.1)	15 (30.6)
Difference vs. placebo (95% CI)	19.9 (4.9 to 34.8)	25.7 (11.6 to 40.3)
P value vs. placebo	< 0.005	< 0.005
Change from baseline to 48 weeks in the MoCA
No. of participants evaluated^b	50	49	49
Median change	3.0	4.0	−3.0
Median difference vs. placebo (95% CI)	6.0 (4.7 to 7.3)	7.0 (5.4 to 8.6)
P value vs. placebo	< 0.005	< 0.005
Change from baseline to 48 weeks in the NPI
No. of participants evaluated^b	50	49	49
Median change	−4.0	−6.0	7.0
Absolute median difference vs. placebo (95% CI)	11.0 (6.9 to 15.1)	13.0 (8.3 to 17.7)
P value vs. placebo	< 0.005	< 0.005
Change from baseline to 48 weeks in the perfusion on the temporoparietal region
No. of participants evaluated^b	11	5	9
Change — no. (%)
Improvement	7 (63.6)	2 (40.0)	0 (0)
No change	3 (27.3)	2 (40.0)	7 (77.8)
Worsening	1 (9.1)	1 (20.0)	2 (22.2)

Scores on the 11-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog11) range from 0 to 70, with higher scores indicating greater impairment (scores were adjusted for age and formal education). Scores on the Clinician’s Interview Based Impression of Change Incorporating Caregiver Information (CIBIC+) range from 0 to 7, with higher scores indicating greater impairment. Scores on the Global Deterioration Scale (GDS) range from 1 to 7, with higher scores indicating greater impairment. Scores on the Montreal Cognitive Assessment (MoCA) ≥ 26/30 normal. Scores on the Neuropsychiatric inventory (NPI) range from 0 to 120, higher scores reflect greater severity
No. Number, IR Interquartile range, CI Confidence interval
^aThe analysis was performed in the modified intention-to-treat population (worst scenario, increase of 10 and 7 points at week 48 in ADAS-Cog11 and CIBIC+ respectively), which included participants who received at least one dose of neuroEPO or placebo and who had a baseline assessment
^bThe analysis was performed in the per protocol population, which included subjects who complied with the protocol sufficiently (more than 90% of treatment with efficacy outcomes at baseline and at 48 weeks without any major deviation of protocol) to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model. Subjects were considerate in their randomized group

Back to article page

ISSN: 1758-9193

Contact us

General enquiries: journalsubmissions@springernature.com