Benefits of use, and tolerance of, medium-chain triglyceride medical food in the management of Japanese patients with Alzheimer’s disease: a prospective, open-label pilot study

Figures & data

Table 1 Clinical data for enrolled patients

Variables	Total patients with AD	Patients with ApoE4	Patients without ApoE4	P-value
	(n=22)	(n=7)	(n=15)
Sex, male/female	12/10	4/3	8/7	NS
Age (years)	63.9±8.5 (48–83)	63.6±4.0 (58–68)	64.1±10.2 (48–83)	NS
Age at onset (years)	58.7±8.7 (46–79)	58.4±4.0 (54–63)	58.8±10.4 (46–79)	NS
Duration of illness (years)	5.2±2.1 (1–9)	5.1±0.9 (4–7)	5.3±2.4 (1–9)	NS
DUD (years)	1.9±1.6 (0–6)	1.4±1.0 (0–3)	2.3±1.7 (0–6)	NS
ADAS	22.4±13.2 (6.3–55.0)	22.7±14.4 (9.3–53.0)	23.1±13.3 (6.3–55.0)	NS
MMSE	18.1±5.1 (10–25)	19.1±6.0 (10–24)	17.8±4.9 (11–25)	NS

Notes: Data are means ± standard deviation (range). Differences in sex distribution were analyzed using χ² test. Differences in other clinical valuables were compared with Mann–Whitney U-test.

Abbreviations: AD, Alzheimer’s disease; DUD, duration of untreated dementia; ADAS, Alzheimer’s Disease Assessment Scale; MMSE, Mini-Mental State Examination; NS, not significant.

Table 2 Symptoms of intolerance to Axona in 24 Japanese patients

	Frequency (%)			US patients*
	Month 1 (n=24**)	Month 2 (n=22)	Month 3 (n=22)	n=86
No adverse effects	22 (91.7)	18 (81.8)	19 (86.4)
Any adverse effects	2 (8.3)	4 (18.2)	3 (13.6)	75.6%
Diarrhea	0	0	1 (4.5)	24.4%
Flatulence	1 (4.2)	1 (4.5)	1 (4.5)	17.4%
Dyspepsia	0	2	0	9.3%
Dizziness	0	0	0	7.0%
Headache	0	0	0	5.8%
Abdominal pain	1 (4.2)	1 (4.5)	1 (4.5)	4.7%

Notes:

* Accera November 2012 (unpublished data);

** two patients dropped out before month 2.

Figure 1 Changes in cognitive functions in Japanese patients with Alzheimer’s disease taking Axona.

Notes: Data presented as means with standard deviation bars. (A) ΔMMSE; (B) ΔADAS.
Abbreviations: MMSE, Mini-Mental State Examination; ADAS, Alzheimer’s Disease Assessment Scale; M, month.

Figure 2 The largest and second-largest increase or decline in the ΔMMSE (A) and ΔADAS (B) between M0 and M3.

Notes: Cases A and B, increase; cases C and D, decrease. Apolipoprotein E genotypes are shown in parenthesis.
Abbreviations: MMSE, Mini-Mental State Examination; ADAS, Alzheimer’s Disease Assessment Scale; M, month.

Table S1 Timing of the physical and mental examinations

	M0	M1	M2	M3
Intolerance	○	○	○	○
Blood test*	○	○	○	○
Serum ketone bodies**	○	○	○	○
ADAS-Jcog	○	○	○	○
MMSE	○	○	○	○

Notes:

* Hemogram, liver function (alanine aminotransferase and aspartate aminotransferase), renal function (creatinine and urea nitrogen), nutrition status (glucose, glycohemoglobin A_1C, low-density lipoprotein and high-density lipoprotein, triacylglycerol, albumin, and total protein), electrolytes (sodium, chloride, and potassium);

** acetoacetic acid and β-hydroxybutyric acid.

Abbreviations: M, month; ADAS, Alzheimer’s Disease Assessment Scale; MMSE, Mini-Mental State Examination; ADAS-J_cog, ADAS cognitive subscale, Japanese version.