Table 3.
Changes in cognition, motor and non-motor symptoms, mood, quality of life, vital signs, and medications between baseline and week 60
| Baseline | 12 weeks | 24 weeks | 36 weeks | 48 weeks | Change (0–48 weeks) |
Adjusted difference (0–48 weeks) |
p value | 60 weeks | Change (0–60 weeks) |
Adjusted difference (0–60 weeks) |
p value | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mattis Dementia Rating Scale* | ||||||||||||
|
| ||||||||||||
| Exenatide | 138·0 (5·0) | 139·0 (6·1) | 139·5 (4·2) | 140·3 (3·7) | 139·7 (4·1) | 1·7 (0·4 to 2·9) | 0·4 (−1·0 to 1·9) | 0·57 | 139·9 (3·6) | 1·9 (0·6 to 3·1) | 0·8 (−0·9 to 2·5) | 0·32 |
| Placebo | 139·8 (3·7) | 140·3 (3·1) | 139·7 (5·8) | 140·3 (4·1) | 140·2 (3·9) | 0·4 (−0·6 to 1·5) | ·· | ·· | 140·2 (4·6) | 0·4 (−1·1 to 1·8) | ·· | ·· |
|
| ||||||||||||
| Unified Dyskinesia Rating Scale | ||||||||||||
|
| ||||||||||||
| Exenatide | 5·4 (7·9) | 5·4 (8·0) | 4·4 (6·5) | 5·6 (7·9) | 5·1 (7·1) | −0·3 (−2·3 to 1·8) | −0·8 (−3·6 to 1·9) | 0·53 | 6·2 (7·2) | 0·8 (−1·7 to 3·3) | −1·6 (−5·1 to 1·8) | 0·35 |
| Placebo | 7·3 (9·4) | 6·8 (9·7) | 6·9 (9·8) | 6·8 (9·9) | 7·4 (10·7) | 0·1 (−1·7 to 1·8) | ·· | ·· | 9·0 (12·4) | 1·7 (−0·8 to 4·2) | ·· | ·· |
|
| ||||||||||||
| MADRS | ||||||||||||
|
| ||||||||||||
| Exenatide | 4·1 (3·7) | 3·4 (3·5) | 2·2 (1·8) | 2·7 (3·1) | 2·5 (2·7) | −1·6 (−3·4 to 0·07) | −1·4 (−3·2 to 0·5) | 0·15 | 2·1 (2·6) | −1·6 (−2·7 to −0·4) | −0·9 (−2·2 to 0·3) | 0·15 |
| Placebo | 3·7 (3·0) | 2·9 (3·8) | 3·5 (4·4) | 3·9 (4·4) | 3·8 (4·2) | 0·2 (−1·8 to 2·2) | ·· | ·· | 2·8 (2·6) | −0·9 (−2·3 to 0·5) | ·· | ·· |
|
| ||||||||||||
| NMSS | ||||||||||||
|
| ||||||||||||
| Exenatide | 24·6 (19·8) | 17·7 (15·4) | 16·4 (12·4) | 16·5 (10·3) | 19·7 (12·4) | −4·9 (−11·6 to 1·8) | −4·0 (−11·8 to 3·8) | 0·30 | 22·3 (14·2) | −2·3 (−9·6 to 5·1) | −3·3 (−11·7 to 5·1) | 0·43 |
| Placebo | 28·3 (24·7) | 22·0 (22·4) | 22·1 (20·2) | 23·1 (21·6) | 25·8 (22·8) | −2·5 (−9·5 to 4·6) | ·· | ·· | 27·6 (23·3) | −1·5 (−9·0 to 6·0) | ·· | ·· |
|
| ||||||||||||
| PDQ-39 summary index | ||||||||||||
|
| ||||||||||||
| Exenatide | 19·9 (13·7) | 17·1 (10·7) | 16·8 (10·6) | 17·2 (11·4) | 18·7 (12·7) | −1·2 (−4·7 to 2·3) | −1·7 (−5·6 to 2·1) | 0·38 | 18·4 (11·1) | −1·5 (−5·4 to 2·4) | −3·3 (−8·0 to 1·5) | 0·17 |
| Placebo | 21·1 (13·0) | 17·8 (10·9) | 18·6 (14·2) | 20·5 (15·6) | 20·1 (12·8) | −1·1 (−4·2 to 2·1) | ·· | ·· | 22·2 (14·8) | 0·3 (−3·4 to 4·0) | ·· | ·· |
|
| ||||||||||||
| EQ5D index* | ||||||||||||
|
| ||||||||||||
| Exenatide | 0·71 (0·20) | 0·72 (0·17) | 0·76 (0·14) | 0·81 (0·14) | 0·74 (0·23) | 0·03 (−0·07 to 0·12) | 0·06 (−0·03 to 0·15) | 0·21 | 0·72 (0·18) | 0·005 (−0·08 to 0·09) | −0·003 (−0·09 to 0·09) | 0·95 |
| Placebo | 0·79 (0·16) | 0·72 (0·19) | 0·77 (0·14) | 0·75 (0·16) | 0·74 (0·14) | −0·05 (−0·10 to 0·00) | ·· | ·· | 0·75 (0·14) | −0·06 (−0·12 to 0·01) | ·· | ·· |
|
| ||||||||||||
| EQ5D VAS (%)* | ||||||||||||
|
| ||||||||||||
| Exenatide | 73·6 (14·5) | 72·3 (13·7) | 71·5 (15·6) | 71·4 (16·6) | 70·1 (15·6) | −3·2 (−8·9 to 2·5) | 6·9 (−1·0 to 14·8) | 0·08 | 68·1 (14·4) | −5·6 (−12·2 to 1·1) | 5·3 (−3·0 to 13·5) | 0·21 |
| Placebo | 74·5 (16·0) | 68·6 (13·2) | 68·5 (18·7) | 69·0 (19·7) | 64·7 (20·5) | −9·3 (−15·4 to −3·1) | ·· | ·· | 65·1 (20·2) | −10·6 (−16·4 to −4·8) | ·· | ·· |
|
| ||||||||||||
| Right hand taps in 30 s* | ||||||||||||
|
| ||||||||||||
| Exenatide (off medication) | 46·5 (9·9) | 48·3 (10·7) | 48·5 (13·8) | 46·9 (12·4) | 47·9 (11·2) | 1·1 (−2·5 to 4·8) | −1·1 (−5·8 to 3·6) | 0·69 | 46·6 (12·1) | 0·4 (−3·0 to 3·8) | 1·1 (−4·3 to 6·4) | 0·64 |
| Placebo (off medication) | 53·9 (13·1) | 54·0 (13·0) | 52·2 (12·2) | 52·9 (11·4) | 50·5 (11·0) | −3·1 (−7·8 to 1·7) | ·· | ·· | 52·7 (9·8) | −1·0 (−4·5 to 2·5) | ·· | ·· |
| Exenatide (on medication) | 52·8 (11·7) | 53·0 (12·0) | 51·5 (11·9) | 51·5 (12·9) | 51·3 (12·9) | −1·5 (−7·0 to 3·9) | −3·2 (−8·4 to 2·1) | 0·28 | 52·6 (11·4) | −0·7 (−5·7 to 4·3) | −3·4 (−9·6 to 2·8) | 0·23 |
| Placebo (on medication) | 59·1 (14·5) | 59·3 (11·6) | 59·3 (12·4) | 59·7 (10·0) | 57·6 (10·3) | −1·3 (−5·9 to 3·4) | ·· | ·· | 58·7 (11·5) | 0·4 (−2·9 to 3·7) | ·· | ·· |
|
| ||||||||||||
| Left hand taps in 30 s* | ||||||||||||
|
| ||||||||||||
| Exenatide (off medication) | 47·8 (9·3) | 48·8 (9·4) | 49·0 (10·5) | 48·3 (8·7) | 47·7 (9·8) | 0·3 (−2·7 to 3·3) | −0·9 (−4·8 to 2·9) | 0·69 | 47·2 (9·7) | −0·6 (−3·8 to 2·6) | 0·2 (−4·0 to 4·4) | 0·62 |
| Placebo (off medication) | 50·6 (11·5) | 52·6 (11·8) | 50·2 (11·0) | 49·9 (10·5) | 49·7 (10·2) | −0·9 (−4·6 to 2·8) | ·· | ·· | 49·5 (9·7) | −0·3 (−3·0 to 2·3) | ·· | ·· |
| Exenatide (on medication) | 52·9 (10·0) | 49·8 (12·7) | 50·6 (10·1) | 50·5 (10·8) | 49·0 (10·2) | −4·1 (−7·4 to −0·9) | −1·2 (−5·2 to 2·8) | 0·18 | 50·9 (12·0) | −2·1 (−5·3 to 1·2) | −2·9 (−7·1 to 1·4) | 0·54 |
| Placebo (on medication) | 56·6 (13·0) | 56·3 (12·1) | 55·8 (10·3) | 56·3 (10·0) | 54·6 (11·9) | −2·2 (−5·6 to 1·2) | ·· | ·· | 54·1 (10·8) | −1·1 (−3·4 to 1·2) | ·· | ·· |
|
| ||||||||||||
| 10 m timed walk (s) | ||||||||||||
|
| ||||||||||||
| Exenatide (off medication) | 17·2 (4·5) | 16·2 (7·8) | 17·3 (9·6) | 16·7 (8·1) | 17·4 (11·1) | 0·2 (−3·1 to 3·4) | 0·8 (−4·6 to 6·1) | 0·69 | 19·5 (16·5) | 2·5 (−2·5 to 7·5) | −0·7 (−4·2 to 2·8) | 0·78 |
| Placebo (off medication) | 17·1 (6·3) | 16·2 (5·4) | 16·4 (7·1) | 14·8 (4·8) | 16·6 (8·8) | −0·5 (−2·9 to 1·9) | ·· | ·· | 19·1 (16·0) | 1·8 (−2·5 to 6·1) | ·· | ·· |
| Exenatide (on medication) | 15·2 (2·7) | 14·9 (3·4) | 14·7 (3·3) | 14·4 (3·3) | 15·1 (5·5) | −0·03 (−1·5 to 1·4) | −1·5 (−4·6 to 1·6) | 0·61 | 15·0 (5·8) | −0·1 (−1·6 to 1·4) | 0·3 (−0·9 to 1·6) | 0·35 |
| Placebo (on medication) | 14·7 (3·1) | 14·3 (3·2) | 14·4 (3·7) | 14·2 (3·3) | 13·6 (3·0) | −1·1 (−1·8 to −0·4) | ·· | ·· | 15·3 (7·5) | 0·6 (−2·4 to 3·7) | ·· | ·· |
|
| ||||||||||||
| Hauser diary: asleep (%) | ||||||||||||
|
| ||||||||||||
| Exenatide | 30 | 29 | 30 | 31 | 30 | ·· | ·· | 28 | ·· | ·· | ·· | |
| Placebo | 26 | 26 | 27 | 27 | 27 | ·· | ·· | 25 | ·· | ·· | ·· | |
|
| ||||||||||||
| Hauser diary (off; %) | ||||||||||||
|
| ||||||||||||
| Exenatide | 17 | 14 | 15 | 12 | 16 | ·· | ·· | 18 | ·· | ·· | ·· | |
| Placebo | 20 | 20 | 17 | 19 | 20 | ·· | ·· | 22 | ·· | ·· | ·· | |
|
| ||||||||||||
| Hauser diary: on without dyskinesia (%) | ||||||||||||
|
| ||||||||||||
| Exenatide | 49 | 53 | 48 | 52 | 49 | ·· | ·· | 50 | ·· | ·· | ·· | |
| Placebo | 49 | 50 | 50 | 48 | 47 | ·· | ·· | 47 | ·· | ·· | ·· | |
|
| ||||||||||||
| Hauser diary: on with non-troublesome dyskinesia (%) | ||||||||||||
|
| ||||||||||||
| Exenatide | 3 | 3 | 5 | 4 | 5 | ·· | ·· | 5 | ·· | ·· | ·· | |
| Placebo | 3 | 2 | 5 | 3 | 4 | ·· | ·· | 4 | ·· | ·· | ·· | |
|
| ||||||||||||
| Hauser diary: on with troublesome dyskinesia (%) | ||||||||||||
|
| ||||||||||||
| Exenatide | 1 | 4 | 2 | 1 | 1 | ·· | ·· | ·· | 5 | ·· | ·· | ·· |
| Placebo | 1 | 2 | 1 | 3 | 2 | ·· | ·· | ·· | 3 | ·· | ·· | ·· |
|
| ||||||||||||
| Mean arterial blood pressure (mm Hg) | ||||||||||||
|
| ||||||||||||
| Exenatide | 95·4 (15·8) | 95·8 (12·1) | 96·2 (11·5) | 93·8 (12·2) | 96·8 (11·0) | 1·4 (−2·7 to 5·6) | ·· | ·· | 95·8 (13·6) | 0·4 (−4·2 to 4·9) | ·· | ·· |
| Placebo | 94·2 (7·9) | 93·1 (11·2) | 93·8 (9·1) | 93·8 (9·5) | 95·0 (9·6) | 0·8 (−2·2 to 3·7) | ·· | ·· | 95·2 (7·6) | 1·3 (−2·1 to 4·7) | ·· | ·· |
|
| ||||||||||||
| Weight (kg) | ||||||||||||
|
| ||||||||||||
| Exenatide | 81·8 (16·6) | 80·0 (16·3) | 79·3 (16·5) | 78·1 (15·9) | 79·2 (16·1) | −2·6 (−4·0 to −1·2) | ·· | ·· | 80·9 (16·6) | −0·9 (−2·6 to 0·7) | ·· | ·· |
| Placebo | 80·8 (12·9) | 80·1 (14·3) | 80·2 (14·0) | 79·5 (13·6) | 80·2 (13·3) | −0·6 (−1·9 to 0·8) | ·· | ·· | 80·5 (14·3) | −0·09 (−1·5 to 1·3) | ·· | ·· |
|
| ||||||||||||
| Levodopa equivalent dose (mg) | ||||||||||||
|
| ||||||||||||
| Exenatide | 773·9 (260·9) | 804·5 (288·3) | 851·7 (336·5) | 849·3 (368·6) | 895·6 (337·7) | 121·8 (47·7 to 195·8) | ·· | ·· | 906·1 (328·8) | 132·2 (61·5 to 203·0) | ·· | ·· |
| Mean change per visit | ·· | 30·6 | 47·2 | −2·4 | 46·3 | ·· | ·· | ·· | 10·5 | ·· | ·· | ·· |
| Placebo | 825·7 (215·0) | 828·8 (225·4) | 897·5 (225·0) | 883·3 (218·9) | 913·0 (243·4) | 87·3 (−2·4 to 177·1) | ·· | ·· | 942·7 (235·2) | 112·6 (40·7 to 184·4) | ·· | ·· |
| Mean change per visit | ·· | 3·1 | 68·7 | −14·2 | 29·7 | ·· | ·· | ·· | 29·7 | ·· | ·· | ·· |
|
| ||||||||||||
| Parkinson’s drugs (n) | ||||||||||||
|
| ||||||||||||
| Exenatide | ||||||||||||
| Levodopa | 31 | 31 | 31 | 31 | 31 | ·· | ·· | 31 | ·· | ·· | ·· | |
| Dopamine agonists | 24 | 25 | 24 | 24 | 24 | ·· | ·· | 24 | ·· | ·· | ·· | |
| Monoamine oxidase B inhibitors | 17 | 17 | 17 | 17 | 17 | ·· | ·· | 17 | ·· | ·· | ·· | |
| Placebo | ||||||||||||
| Levodopa | 29 | 29 | 29 | 29 | 29 | ·· | ·· | 29 | ·· | ·· | ·· | |
| Dopamine agonists | 23 | 23 | 25 | 25 | 25 | ·· | ·· | 25 | ·· | ·· | ·· | |
| Monoamine oxidase B inhibitors | 13 | 13 | 14 | 14 | 15 | ·· | ·· | 15 | ·· | ·· | ·· | |
Data are mean (SD) or mean (95% CI), except for data for Parkinson’s drugs, which are n. All scores are for the on-medication state, unless otherwise specified. MADRS=Montgomery-Asberg Depression Rating
Scale. NMSS=Non-Motor Symptoms Scale. PDQ-39=Parkinson’s Disease Questionnaire 39. EQ5D=EuroQol Five Dimensions Questionnaire. VAS=visual analogue scale.
*
Higher scores show improved status.