Table 3.
Patients With Alzheimer's Disease Experiencing Adverse Events During Randomized Treatment With Methylphenidate or Placeboa
| Effect | Methylphenidate (n = 29) | Placebo (n = 31) | ORb | 95% CI | P Value |
|---|---|---|---|---|---|
| No. of patients with adverse event data, nc | 29 | 29 | |||
| Event | |||||
| Death, n | 0 | 0 | |||
| Serious adverse events, n | 1 | 1 | |||
| Abdominal pain | 1 | 0 | |||
| Drop in hemoglobin | 0 | 1 | |||
| Abnormal ECG results at wk 6, n (%)d | 20 (77) | 15 (58) | 2.4 | 0.6 to 9.9 | .24 |
| Clinically significant abnormal ECG results at wk 6, n | 1e | 0 | |||
| Weight loss at week 6 > 7%, n | 0 | 0 | |||
| Weight loss at week 6 > 2%, n (%) | 10 (40) | 4 (15) | 3.7 | 0.9 to 19.4 | .06 |
| Any hallucinations and/or delusions, n (%) | 5 (18) | 4 (14) | 1.4 | 0.3 to 5.7 | .67 |
| Significant hallucinations and/or delusions, n (%) | 2 (7) | 0 (0) | … | … | .24 |
| Side effects collected via prompted questions, n (%) | |||||
| Abdominal pain | 6 (21) | 4 (14) | 1.6 | 0.4 to 6.5 | .49 |
| Aggressive behavior or hostility | 9 (31) | 5 (17) | 2.2 | 0.6 to 7.5 | .22 |
| Agitation | 17 (59) | 13 (45) | 1.7 | 0.6 to 4.9 | .29 |
| Angina | 2 (7) | 1 (3) | … | … | 1.00 |
| Anorexia | 6 (21) | 5 (17) | 1.3 | 0.3 to 4.7 | .74 |
| Anxiety, nervousness, or tension | 17 (59) | 10 (34) | 2.7 | 0.9 to 7.8 | .07 |
| Arthralgia | 6 (21) | 14 (48) | 0.3 | 0.1 to 0.9 | .03 |
| Blood pressure changes | 4 (14) | 3 (10) | 1.4 | 0.3 to 6.8 | .69 |
| Blurry vision or eyesight changes | 0 (0) | 3 (10) | … | … | .24 |
| Decreased appetite | 8 (28) | 7 (24) | 1.2 | 0.4 to 3.9 | .76 |
| Depressed mood | 12 (41) | 12 (41) | 1.0 | 0.4 to 2.8 | 1.00 |
| Distractibility | 11 (38) | 8 (28) | 1.6 | 0.5 to 4.9 | .40 |
| Dizziness | 11 (38) | 7 (24) | 1.9 | 0.6 to 6.0 | .26 |
| Drowsiness | 10 (34) | 13 (45) | 0.6 | 0.2 to 1.9 | .42 |
| Dry mouth | 7 (24) | 6 (21) | 1.2 | 0.4 to 4.2 | .75 |
| Dyskinesia | 1 (3) | 4 (14) | … | … | .35 |
| Hair loss | 2 (7) | 1 (3) | … | … | 1.00 |
| Headache | 5 (17) | 4 (14) | 1.3 | 0.3 to 5.4 | .72 |
| Hyperactivity | 5 (17) | 1 (3) | … | … | .19 |
| Impaired learning | 4 (14) | 7 (24) | 0.5 | 0.1 to 2.0 | .32 |
| Nausea | 3 (10) | 7 (24) | 0.4 | 0.1 to 1.6 | .18 |
| Skin rash, redness, or inflammation | 6 (21) | 6 (21) | 1.0 | 0.3 to 3.6 | 1.00 |
| Tics (motor or verbal) | 0 (0) | 4 (14) | … | … | .11 |
| Side effects collected via open-ended questions, n (%) | |||||
| Related to increased bleeding | 1 (3) | 3 (10) | … | … | .61 |
| Related to increased motor activity | 6 (21) | 2 (7) | … | … | .25 |
| Other, not related to bleeding or motor activity | 14 (48) | 11 (38) | 1.5 | 0.5 to 4.9 | .60 |
The following events were reported by 2 or fewer patients in both treatment groups and were not included in this table: abnormal liver function, anemia, fever, impulsivity, palpitations, pulse changes, urticaria, tachycardia, and vasculitis.
Odds ratios (ORs) and P values were calculated using logistic regression or Fisher exact (for small cell counts). A patient was counted as having the event if he/she reported the symptom during any follow-up visit.
Two randomized patients (placebo) had no data on adverse events during follow-up. One additional patient (methylphenidate) was missing data on delusions and hallucinations at week 6. Four patients in the methylphenidate group and 4 patients in the placebo group were missing baseline or week 6 weight. Three patients taking methylphenidate and 5 patients taking placebo were missing week 6 ECG.
Among those participants with normal ECG at baseline, 4 participants taking methylphenidate and 4 participants taking placebo had abnormal ECGs at week 6.
Left atrial enlargement, prolonged QT interval.
Abbreviation: ECG = electrocardiogram.